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The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team : The Quality Management Systems (QMS) team at Dexcom plays a critical role in ensuring the integrity, compliance, and scalability of our global quality framework. As a strategic function within Global Quality, the team is responsible for maintaining a robust, compliant, and continuously improving QMS that supports product development, manufacturing, and post-market activities across all regions. We partner cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams to embed quality into every stage of the product lifecycle. Our mission is to enable innovation while maintaining the highest standards of safety, compliance, and patient impact. As Dexcom continues to grow globally, the QMS team ensures our processes evolve to meet increasingly complex regulatory requirements while staying efficient and scalable. Where you come in: As the Sr. Director of Quality Management Systems, you will provide strategic leadership and oversight for Dexcom’s global QMS, ensuring it meets all applicable regulatory requirements (FDA, ISO 13485, MDR, and other international standards) while supporting business growth and innovation. You will: Own and evolve the global QMS strategy, ensuring alignment with corporate objectives and regulatory expectations Lead the design, implementation, and /or continuous improvement of key QMS processes, including document control, CAPA, metrics and analytics, partnership management, audit management, among others. Own the corporate CAPA program, ensuring world class execution and performance. Drive harmonization and standardization of quality processes across global sites and regions Establish a Quality I ntelligenc e program that focuses on risks and developments across the medical device industry. Own Project M anagement for the Quality organization, focusing on continuous improvement opportunities. Ensure inspection readiness at all times and assist with enterprise-level responses to regulatory inspections and audits Partner closely with Regulatory Affairs to interpret evolving global regulations and proactively integrate requirements into the QMS Build, develop, and lead a high-performing, global QMS team Champion a culture of quality, compliance, and continuous improvement across the organization Leverage digital tools and data analytics to modernize and scale the QMS, improving efficiency and visibility Provide executive-level reporting on QMS performance, risks, and improvement initiatives What makes you successful: You are a strategic, forward-thinking quality leader who can balance compliance with agility in a fast-paced, innovation -driven environment. Leadership & Influence Proven ability to lead and scale global teams, driving alignment across functions and geographies Strong executive presence with the ability to influence senior leadership and cross-functional stakeholders Quality & Regulatory Expertise Deep knowledge of global QMS requirements, including FDA 21 CFR Part 820, ISO 13485, EU MDR, and other international standards Demonstrated success leading regulatory inspections and audits with positive outcomes Experience building or transforming QMS frameworks in a complex, global organization Operational Excellence Track record of implementing scalable, efficient quality processes that support rapid business growth Strong systems mindset with experience driving digital transformation within QMS platforms (e.g., eQMS systems) Data-driven decision-maker who uses metrics to drive continuous improvement Strategic Mindset Ability to anticipate regulatory trends and corporate needs, and proactively adapt systems and processes Strong business acumen with an understanding of how Q uality enables innovation and market success Collaboration & Communication Excellent cross-functional collaboration skills, with the ability to translate complex regulatory requirements into practical, business-friendly solutions Clear and compelling communicator, capable of engaging audiences from frontline teams to executive leadership What you’ll get : A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and c omprehensive benefit s progra m . Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursemen t. A n exciting and innovative , industry - leading organization committed to our employees , customers , and the communities we serve . Travel Required: 15- 25% Experience and Education Requirements: Typically requires a Bachelor’s degree with 17+ years of industry experience 13+ years of years of successful leadership experience in relevant industry Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected]. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $209,600.00 - $349,300.00
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Job Title: Manufacturing Technician 2 – Monday – Friday, 2nd shift Where you come in: This list contains tasks that are typically associated with the job. It is not all-inclusive and Dexcom may, depending on the specific nature of the position, modify these tasks and/or identify additional tasks, based on business needs. You will be responsible for set up, changeover, and shut down of pilot production equipment You will routinely monitor pilot production equipment. Adjust equipment setting parameters to optimize equipment performance. You will replace, request, and maintain new fixtures. Order new tools and replacement parts. You will assist in developing methods and procedures to control or modify manufacturing process You will read manufacturing LHRs, MPIs, and engineering study instructions You will work with engineers in conducting engineering experiments You will assist engineers in set-up and calibration tasks, and quality testing related to the production of pilot parts, components, subassemblies and final subassemblies You will update equipment records in record keeping system as needed You may assist with equipment qualifications (IQs, OQs, PQs). This position assumes and performs other duties as assigned What makes you successful: You demonstrate extensive knowledge of and ability to: Interpret and understand engineering study protocol Previous suitable experience in a similar role Your experience using problem solving methodologies to establish root cause Your experience in working independently in a production environment Your flexibility and collaboration taking instruction from manufacturing and engineering Maximize production performance focused on quality delivery and cost Work in a cross functional team What you’ll get: A front row seat to life changing CGM technology A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 0% Experience and Education Preferred: Experience in a pilot manufacturing environment is a plus Experience and Education Requirements: Typically requires a minimum of 2-4 years of related experience and High School diploma/certificate or equivalent Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected]. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $23.70 - $35.52
Description: Mail Production Team Member – Bindery & Inserting Position Overview Anderson is currently hiring for multiple openings within our Mail Production Department, with opportunities available in both Bindery and Inserting operations. These are hands-on production roles supporting the preparation, finishing, and mailing of printed materials for our clients. We are seeking dependable, detail-oriented individuals who take pride in quality work, can thrive in a fast-paced production environment, and are willing to learn and grow with the company. Compensation Pay range: $18 – $25 per hour, depending on experience. Bindery Production Team Member The Bindery team supports the finishing side of print production, including: Cutting Folding Stitching Sorting Preparing jobs for mailing or delivery Inserting Production Team Member The Inserting team supports mail production operations by: Operating and assisting with mail inserting equipment Preparing materials for machine processing Monitoring production quality Sorting and traying mail Keeping production running accurately and efficiently Responsibilities Follow production schedules and job instructions accurately Maintain high standards for quality, accuracy, and attention to detail Work collaboratively as part of a production team Stand for extended periods and perform repetitive production tasks Lift, move, and handle printed materials and production supplies Maintain a clean, organized, and safe work environment Meet productivity and attendance expectations Work overtime as needed to meet production deadlines and customer demands Maintain flexibility with shift schedules and work hours based on operational and business needs Why Join Anderson Anderson is a long-standing, stable company with a strong reputation for quality, service, and teamwork. Our production teams play a critical role in delivering accurate, high-quality work for our clients every day. Requirements: Qualifications Previous experience in bindery, mail production, printing, inserting, fulfillment, warehouse operations, or machine operation is preferred but not required Ability to work in a fast-paced manufacturing or production environment Strong attention to detail and commitment to quality Dependable, punctual, and team-oriented Willingness to learn and take direction
ABOUT THE BRAND: Callaway Golf Company is a premium golf equipment, gear and apparel company with a portfolio of global brands, including Callaway Golf, Odyssey, TravisMathew, and OGIO. Through an unwavering commitment to innovation and premium craftsmanship, Callaway designs, manufactures, and sells high-performance golf clubs, golf balls, apparel, bags, and other accessories—setting the standard for performance in the game of golf. Our Mission: To create demonstrably superior and pleasingly different products powered by innovative technology and premium craftsmanship enabling golfers of all abilities to play their best and find more joy in the game. Our company is a blend of experience and diverse backgrounds, and together we look to leave the past behind while moving the game forward. For more information, please visit https://www.callawaygolf.com JOB OVERVIEW The Associate Prototype Technician supports the R&D prototyping team in the machining, fabrication, assembly, finishing, and inspection of prototype components used for product development and testing. Working under the guidance of Prototype Technicians and engineers, this role assists in reducing prototype manufacturing lead time through machining support, fixture preparation, prototype assembly, and accurate documentation. This position operates in a hands-on prototype shop environment focused on learning CNC machining processes, prototype fabrication methods, quality standards, and modern manufacturing practices. The Associate Prototype Technician is expected to demonstrate strong attention to detail, adaptability, and the ability to work collaboratively in a fast-paced team environment. ROLES AND RESPONSIBILITIES Assist in the machining, fabrication, assembly, and finishing of prototype components using engineering drawings, CAD models, sketches, and verbal instructions. Support setup and operation of CNC mills, lathes, grinders, and other prototype shop equipment while performing basic machining operations under supervision. Prepare raw materials, tooling, fixtures, and setup components required for prototype manufacturing activities. Perform dimensional inspections using precision measurement tools to verify compliance with specifications and quality standards. Assist with prototype fitting, polishing, deburring, and light assembly activities. Support engineers and senior technicians in resolving manufacturability challenges and meeting rapid prototype development timelines. Maintain accurate build records, inspection data, and material tracking using established systems and procedures. Perform routine equipment cleaning, preventative maintenance, and basic troubleshooting while maintaining a safe and organized shop environment. Communicate effectively with engineers, technicians, designers, and supervisors regarding project priorities and status. Demonstrate flexibility, attention to detail, and willingness to learn new machining technologies and prototype manufacturing processes. TECHNICAL COMPETENCIES (Knowledge, Skills & Abilities) Basic understanding of CNC machining, prototype fabrication, and shop safety practices. Ability to read and interpret engineering drawings, CAD models, blueprints, sketches, and basic tolerances. Familiarity with CNC mills, manual machining equipment, hand tools, and fabrication tools used in prototype manufacturing environments. Ability to use precision measurement equipment such as calipers, micrometers, gauges, rulers, and scales to verify component quality and accuracy. Fundamental knowledge of fixturing, prototype assembly, and quality inspection methods. Basic computer proficiency and familiarity with digital manufacturing systems and Windows-based applications; exposure to NX, Teamcenter, or Shop Floor Connect is a plus. Strong mechanical aptitude, attention to detail, organizational skills, and ability to follow established procedures accurately. Effective communication and teamwork skills with the ability to adapt to changing priorities in a fast-paced R&D environment. Willingness to learn new machining technologies, manufacturing methods, materials, and prototype development processes. EDUCATION AND EXPERIENCE High School Diploma or equivalent required. Associate degree, technical certification, or coursework in machining, manufacturing, or a related technical field preferred. 0–2 years of experience in a machine shop, prototype shop, manufacturing, fabrication, or related technical environment preferred. Prior exposure to CNC machining, machining fundamentals, fabrication, benching, or assembly is a plus. Welding, grinding, polishing, or other prototype finishing experience is a plus but not required. PHYSICAL REQUIREMENTS / WORK ENVIRONMENT (if applicable) Work is performed in a production and prototype shop environment. Regular operation of production and prototype machinery, tools, and equipment. Frequently required to stand, bend, squat, kneel, reach, and perform repetitive hand and arm movements. Regular use of hands for grasping, fine manipulation, and tool operation. Ability to lift and carry up to 50 pounds with or without reasonable accommodation. Vision requirements include close vision, distance vision, depth perception, and the ability to adjust focus. Regular exposure to noise, dust, fumes, oils, and shop chemicals while working around moving mechanical equipment. Required to follow all safety procedures and wear appropriate personal protective equipment (PPE) within the shop environment. DISCLAIMER This job description indicates in general terms, the type and level of work performed as well as the typical responsibilities of employees in this classification and it may be changed by management at any time. Other duties may also apply. Nothing in this position description changes the at-will employment relationship existing between the Company and its employees. Distribution of this item outside of the Company without an authorized release is a violation of Company policy. DE&I and EEOC: Inclusion & Diversity: As a purpose-led, performance driven company, we strive to foster a culture of belonging based on respect, connection, openness and authenticity. We are committed to building and maintaining a workplace that celebrates the diversity of our associates, supporting them to bring their authentic selves to work every day. If your experience is close to what we’re looking for, please consider applying. Experience comes in many forms, skills are transferable, and passion goes a long way. We know that diverse backgrounds and experiences make for the best problem-solving and creative thinking, which is why we’re dedicated to adding new perspectives to the team and encourage everyone to apply. We look forward to learning more about you. ARE YOU READY TO MAKE THE TURN? APPLY TODAY! 18.61 - 23.23 - 27.84 USD Hourly
By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. Pay Range: $25.60 - $35.20 Position Summary: Responsible for processing and formulation of controls, calibrators, working solutions, and intermediates according to approved standard operating procedures. Responsible for manufacturing quality products on schedule. General knowledge and basic application of concepts, theories, terminology and practices that apply to manufacturing in a laboratory environment. Duties and Responsibilities: Prepare products using approved procedures and keep detailed and accurate records Perform in process analysis and determine adjustments to bring analytes into specification Analyze products, stock solutions, and raw materials using automated and manual instrumentation Evaluate that the analysis instrumentation and procedure is operating correctly, and verify or perform maintenance before use Measure accurately quantities of material volumetrically and gravimetrically, employing knowledge of chemical and biochemical properties and handling procedures Continually evaluate and/or create work instructions, QCRs, SOPs and other documents and procedures for effectiveness and modify through formal change process. Perform processing steps as required in the documentation such as centrifugation, diafiltration, in-process filtration, and column separation Perform final release testing Perform aseptic procedures such as aliquoting, filtration, and microbial plating Perform assay testing for Value Assignment as required Assist in developing ways to increase efficiency and/or reduce costs Assist with overall maintenance and cleanliness of the laboratory and equipment Strong attention to detail, maintain clear detailed and accurate records Perform additional functions as required Knowledge, Skills, and Abilities: Ability to show initiative and to perform in a multi-task environment Good interpersonal and verbal/written communication skills. Ability to work with personnel of all levels Ability to perform in a GMP and GLP environment. Knowledge of QSR and ISO Familiarity with biohazardous material handling and chemical safety procedures Minimum Job Requirements: Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred with 0-2 years work experience in In Vitro diagnostics, medical device, pharmaceutical or related industry required. Why Join Bio-Techne: We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield. We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA. We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more. We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging. We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an E-Verify Employer in the United States. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Roche is strongly committed to an inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing inclusion and belonging enables us to create a great place to work and to innovate for patients. The Strategic Quality Partner acts as a single point of contact within project teams (New product development / Product Change) for a portfolio of products assigned to them. The SQP leads and drives for decisions for strategic topics from a compliance and product quality perspective. The SQP partners with internal and external stakeholders across the value chain to accelerate the development process and incorporate learnings. Stakeholders include, but are not limited to Development Leads, Project Leaders, Regulatory Affairs, Operations, Global Customer Support, and Post-Market Quality. The Opportunity • Ensure consistent interpretation& implementation of global requirements across Customer Areas (CAs) • Incorporate lessons learned from all areas of quality across Customer Areas (CA) into project support and ensure PostMarket Quality feedback is built into the requirements • Ensure development project plans contain the right deliverables according to the Design& Development module to deliver safe and compliant solutions • Support internal and external audits • Lead and facilitate constructive discussions e.g. at project team meetings • Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality& Regulatory decision making; prepare and enable risk-based decisions • Partner to ensure effective resolution of issues (e.g. CAPA, NC) • Ensure effective feedback loops and information flow for milestone review. Who You Are • Bachelor's degree in science, engineering, business administration or a related field. MBA or advanced degree is considered an advantage. • 8+ years of experience in the diagnostics industry or a related field in business related functions • Strong scientific and technical background with sound product knowledge, ideally with assay/reagents/system/hardware/software development experience for IVD Products. • Strong business and financial acumen with an enterprise mindset • Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, ISO 14971, GDP, GMP, others) • Excellent communication, presentation, and negotiation skills. • Strong agile knowledge and capabilities demonstrating new ways of working • Pragmatic decision making and ability to move forward without a perfect solution • Demonstrated thorough E2E understanding for lifecycle management • Strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change. Locations You are located in Carlsbad, CA. This is a primarily onsite role. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of Carlsbad is $103,800 and $221,780. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Who we are GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California. GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this formAccommodations for Applicants.
About Nucleus Biologics: At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. About the role The Senior Quality Engineer is responsible for ensuring compliance with regulatory requirements (i.e. ISO 9001, ISO 13485, and EXCiPACT) and internal quality standards. This role leads the Environmental Monitoring and Stability programs, provides critical support for Aseptic Process Validation and Process/Equipment Validation activities, and drives Operational Excellence initiatives. The Senior Quality Engineer works cross-functionally to uphold the highest standards of product quality and continuous improvement. The ideal candidate for this role will be willing to be 100% onsite and work a flexible schedule that allows for coverage in the afternoon/evenings to support critical manufacturing runs. The ideal candidate for this role will be willing to be 100% onsite and work a flexible schedule that allows for coverage in the afternoon/evenings to support critical manufacturing runs. What you'll do RESPONSIBILITIES: Stability Program Oversight Manage the end-to-end stability program, including onboarding new studies, maintaining the stability schedule, and ensuring timely execution of all stability protocols. Author and review stability study protocols, ensuring alignment with regulatory requirements and product-specific objectives. Ensure the timely completion of stability testing by coordinating with internal and external testing needs. Review stability data and results throughout the study lifecycle, identifying trends and flagging out-of-trend or out-of-specification results for investigation. Complete interim and final stability reports as required, ensuring accuracy, completeness, and regulatory compliance. Maintain stability program documentation within the Quality Management System (QMS). Aseptic Process Validation Support Support aseptic process validation (APV) activities, including Media Fills and related studies, in collaboration with the Validation and Manufacturing teams. Author and review APV protocols, ensuring scientific rigor and alignment with current regulatory guidance (e.g., FDA Aseptic Processing Guidance, Annex 1). Conduct thorough review of executed APV protocols, verifying data integrity and compliance with acceptance criteria. Generate and finalize APV summary reports, ensuring all deviations, investigations, and conclusions are appropriately documented. Serve as the Quality point of contact for aseptic process validation inquiries and regulatory submissions as needed. Process & Equipment Validation Support Collaborate cross-functionally with the Validation team to support the creation, review, and routing of process and equipment validation protocols and reports. Provide Quality oversight and approval for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation. Ensure validation activities align with applicable regulatory requirements, internal SOPs, and industry best practices. Participate in risk assessments and validation planning activities to prioritize and scope validation efforts appropriately. Support the resolution of validation-related deviations and contribute to continuous improvement of the validation program. Environmental Monitoring Execute and support Environmental Monitoring (EM) program in accordance with established protocols and regulatory requirements. This includes routing EM, personnel monitoring and water sampling. Assist with the review and analysis of EM, personnel monitoring, and water testing data to identify trends, adverse events, and opportunities for improvement. Assist with investigations related to EM excursions, initiating appropriate corrective actions as needed. Product Release Support Review batch records, manufacturing documentation, and associated data to ensure accuracy, completeness, and compliance with established procedures and regulatory requirements. Support the execution and/or review of Quality Control related activities necessary for raw material and finished good releases. Operational Excellence Conduct analyses of existing quality and business processes to identify inefficiencies, bottlenecks, and areas for improvement. Collaborate with cross-functional teams to develop and implement process improvement initiatives aimed at enhancing operational efficiency and effectiveness. Partner with senior leadership to align Operational Excellence initiatives with strategic business objectives and priorities. Develop and monitor key performance indicators (KPIs) to demonstrate and communicate the results of improvement initiatives. Support the development and delivery of training related to quality processes and improvement activities. Qualifications EDUCATION: Bachelor’s degree in Life Sciences, Microbiology, Biology, or a related field. A combination of education and/or relevant job experience may be considered. REQUIRED EXPERIENCE: 5-7 years of experience within the pharmaceutical, biotechnology, or related regulated industry. Experience with environmental monitoring, water testing, and microbiological/chemical testing methodologies preferred. Including familiarity with gowning practices to execute processes within an ISO 5 and ISO 7 environment. Strong organizational skills with attention to detail and the ability to manage multiple tasks. Experience managing stability programs, including protocol authorship, study execution oversight, and report generation. Familiarity with Aseptic Process Validation (e.g., Media Fill programs) and process/equipment qualification activities (IQ/OQ/PQ). Strong knowledge of GMP, ISO (9001/13485), USP standards and applicable regulatory requirements related to EM, stability, and validation. Ability to execute routine testing such as pH, Conductivity, Endotoxin, Density, Osmolality and Appearance. Experience with Quality Management Systems (QMS) and electronic documentation platforms. Excellent problem-solving, analytical, and organizational skills with a high attention to detail. Strong communication and leadership abilities, with experience collaborating across cross-functional teams. ADDITIONAL SKILLS: Ability to independently develop and manage projects and timelines Familiarity with the execution of Celsis testing is a plus PHYSICAL REQUIREMENTS: Ability to hear and speak to employees and external associates on the phone and in person. Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions [for manufacturing positions only] Ability to lift at 25 lbs. to a height of 3-4 feet on a regular basis. TRAVEL REQUIREMENTS: May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position. NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Production Chemist. Under minimal ongoing supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP under the direction of senior staff including manufacturing products within QSR and ISO regulations This position will be onsite in San Diego, CA. The Responsibilities Carries out production tasks in support of manufacturing goals and objectives Participates in Lean Initiatives Operates laboratory equipment safely, as trained and directed, in accordance with established practices Maintains records and notebooks as directed in a neat, thorough and accurate manner. Perform required data entry on company planning and materials management system Ensures materials are appropriately labeled, approved for use and in sufficient quantity to complete required tasks Reviews/reconciles documents and work orders. Writes/revises documentation as needed Supports product transfers May Train other chemists/lab technicians Partners with the planners, provide input into weekly schedule Initiates and participates in lead document revisions to ensure accurate BOM's process descriptions, NCMR and deviations Operates laboratory equipment and perform routine maintenance/repair Follows all safety guidelines, manufacturing policies and procedures. Operate under strict QSR and ISO compliance Performs complex formulations, component and material evaluations, equipment calibrations and maintenance Formulates complex chemistries and solutions as directed, following established guidelines and procedures Carries out duties in compliance with established business policies Performs other duties & projects as assigned Participates in product/process troubleshooting and validations Carries out functions which may require multiple task coordination Covers on call assignment and complies with all restrictions and requirements Assesses issues affecting departmental performance, Quality standards, and product quality Individually communicates to management and initiates appropriate corrective action Supports departmental troubleshooting, cross-functional projects and process improvement teams Perform other work-related duties as assigned The Individual Required: High School Diploma plus 5-8 years of related work experience in a GMP environment, or BA or BS in Chemistry, Biological Sciences, and 2-4 years of related experience in a GMP environment, or Master’s degree in Chemistry, Biological Sciences, or equivalent and 0-2 years of related experience in GMP environment required Ability to follow detailed instructions, maintains accurate records and notes, and carries out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices Knowledge of a variety of lab equipment and their operation Ability to carry out experiments following established guidelines and summarize results accurately Strong problem-solving and troubleshooting skills Strong verbal and written communication skills Organized and detail oriented Ability to work in a team environment General computer knowledge Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities This position is not currently eligible for visa sponsorship. Preferred: Previous training and experience in the operation of lab equipment and use of lab chemicals and tools preferred. The Key Working Relationships Internal Partners: Manufacturing, Materials, Technical Support and Quality Assurance The Work Environment The work environment characteristics are representative of an office, laboratory, and manufacturing environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. The Physical Demands Position requires ability to lift up to 30 lbs. on a regular basis. Up to 75% of time at lab or production environment, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $67,303.53 - $75,000.00 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected] . #LI-HF1
Hunter Industries is seeking an Electrical Manufacturing Engineer to join our Contract Manufacturing team! In this role you will identify and implement manufacturing processes, procedures, and projects focused on minimizing product cost, improving product quality, and maintaining product availability for assigned product lines. You will work on projects across multiple departments that are aligned with the organization’s strategic objectives. *We are considering all skill levels for this role. If you are unsure if you qualify and don't check all the boxes, or check them all and then some, we encourage you to apply! Essential Functions: Responsible for the resolution of manufacturing issues of assigned product lines that affect product quality and/or availability. Develops and coordinates the necessary processes and sustaining engineering protocols to ensure manufacturing operational efficiencies. Maintains manufacturing-related documentation and production reports that define key metrics and outline current activities. Uses lean manufacturing practices and Six Sigma methodology to evaluate and improve assembly line performance per established key performance indicators. Implements improvement processes to ensure that projects are justifiable, on schedule and within budget. Provides manufacturing engineering support for complete integration of new products into full production per the organization’s New Product Development and Introduction (NPDI) process. Provides focus on delivering a repeatable process with high quality yield. Supports the concurrent engineering effort on behalf of manufacturing as a member of the product development team. Maintains updated capacity models for both injection molds and assembly equipment for assigned product lines. Submits capital requests as required to ensure timely completion of equipment to meet forecasted production. Provides capital requirements for annual budgeting process. Leads or supports cost reduction projects including qualification of new vendors for materials or parts. Participates in test plan development and execution. Evaluates current products, production lines, and processes to pinpoint areas for improvement, and submits recommendations for review. Develops BOMs, test procedures and other related documentation required to support new products. Works with various departments to transfer new designs into production. Supports Incoming Inspection and Warranty Test by providing technical support for failure analysis. Works with Engineering to prioritize product improvements based on trend analysis. Education/Training Required and Preferred: Bachelor’s degree in Electrical Engineering is required. Experience Required and Preferred: 2+ years of engineering experience within a manufacturing organization. Experience working with electromechanical products is preferred. What You Bring: Knowledge of business and management principles involved in strategic planning, resource allocation, production methods, and coordination of people and resources. Knowledge of the practical application of engineering science and technology. This includes the knowledge of LEAN Manufacturing & Six-Sigma methodology techniques and how it can be applied in the manufacturing environment. Ability to speak and write effectively as appropriate for the needs of the audience. Excellent written and verbal communication skills in English, with strong report-writing and presentation skills. Strong computer knowledge including several Microsoft Office programs. Logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Excellent attention to detail, organizational and time management skills, and the ability to work within timelines. Excellent judgment and decision-making skills, with the ability to consider the relative costs and benefits of potential actions to choose the most appropriate one. Ability to travel domestically and internationally and work flexible hours to visit supplier facilities worldwide. Ability to obtain a valid passport, if necessary. Experience with electronics assembly and injection molded plastic components preferred. Knowledge of SPC, FMEA, DOE and process capability studies preferred. Experience with irrigation products or industry preferred. What We Offer: Amazing corporate culture - we walk the walk when it comes to our values! Beautiful 20 acre park like campus with creek and walking trails On site wellness center with personal training, fitness classes and massage FUN company events! Company donation matching and volunteer rewards Career development opportunities and profit sharing bonus Follow us on LinkedIn, check out our rave reviews on Glassdoor, and learn more about our company culture on our career site: http://corporate.hunterindustries.com/careers Hunter is a global leader in the irrigation, outdoor lighting, dispensing technology, and custom manufacturing industries. Driving our continued success is the combined energy and talents of the nearly 4,000 people on our team. Together, we create a diverse array of products that can be seen all over the world, from residential landscapes to national landmarks, stadiums, parks, hotels, and municipal buildings. Hunter Industries and its Family of Companies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability, gender, gender identity or expression, military and veteran status, national origin, race, religion, sexual orientation, or any other applicable legally protected status or characteristic. The salary for this opportunity ranges from $80,000 - $115,000 The Company complies with all federal/local/state regulations in regard to pay. The above represents the expected salary range for this job requisition. Compensation offered to the successful candidate will be determined by qualifications, prior experience, other job-related factors, and geographic location.
The Quality Engineer (QE) will be responsible for product compliance with internal and customer requirements. These spans conception to completion. In addition, the QE will develop, coordinate, improve, evaluate, and maintain the quality assurance program. Prior quality assurance experience and familiarity with industry standards (e.g. J-STD-001, IPC-A-600, IPC-A-610, IPC/WHMA-A-620, ISO9001, AS9100) is required. The QE must have an aptitude and eagerness to learn, speak up when problems arise, and follow the process. They must be a self-starter with great time management skills and very strong attention to detail. Responsibilities Inspect PCBs, PCBAs, machined parts, mechanical assemblies, cable assemblies, optical assemblies, and sub-assemblies, as necessary Read and confirm compliance to Assembly Drawings, Bill of Materials (BOMs), Wire List, Engineering Drawings, Change Orders, and Rework Instructions Use of calipers, go/no go gages, microscopes, torque drivers, micrometers, digital multimeters, etc. as needed for ensure product compliance Identify and segregate nonconforming items per the internal process Validate test stations are configured, as required, per test procedures Witness testing and provide oversight to ensure compliance to requirements Generate First Article Inspection Reports (FAIRs) per AS9102 Audit the quality system for compliance and implement actions to address non-conformances Generate and evaluate quality metrics to identify issues/trends and implement corrective/preventive actions to address nonconformances Manage Corrective and Preventive Action (CAPA) Requests, Nonconforming Material Reports (NCMRs), etc. Participate in design reviews and review/approve documentation change orders Recommend procedural or manufacturing process changes for continuous improvement Prepares statistical analysis reports, specifications, and other technical documents. Generate End Item Data Packages (EIDPs) and support Customer Source Inspection (CSI) Facilitate Manufacturing Review Boards (MRBs) and Failure Review Boards (FRBs) Interface with external customers Qualifications Bachelor's Degree preferred or 5+ years of experience J-STD-001, IPC-A-610, and/or WHMA/IPC-A-620 certifications a plus Familiarity with calipers, go/no gages, microscopes, torque drivers, micrometers, etc. Basic understanding of Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 Familiarity with AS9100/ISO 9001 Quality Management Systems The ability to read engineering drawings, specifications, statements of work, and contracts Effective communication skills with all levels of the organization Close attention to detail and the ability to work independently or with a team Excellent MS Office skills and a willingness to travel, if required Must be a US Person (This position has export control and security-related requirements that mandate attention to the citizenship status of any potential candidate and necessitates that the individual either be a United States Citizen, Permanent Resident of the United States, or lawfully admitted into the United States as a refugee or granted asylum by the United States Government.) About Blue Marble Communications Blue Marble Communications designs and manufactures high-performance RF, free-space optical, and network communications modules and systems for deployment onboard satellites and other space vehicles. Our current product offerings include software-defined RF, microwave, and millimeter-wave modem/transceivers; optical laser communications terminals, Ethernet routers/switches, and systems comprised of combinations of these modules. BMC embraces a modern workplace culture and inclusive environment.
Production Operator Join our dynamic team in Oceanside, CA, 92056, as a Production Operator! We are looking for motivated individuals who thrive in a fast-paced environment and are eager to contribute to our production processes. If you have a keen eye for detail and a passion for quality, we want to hear from you! Overview As a Production Operator, you will play a crucial role in our manufacturing operations. You will be responsible for ensuring that our production lines run smoothly and efficiently while maintaining the highest standards of quality. This is an excellent opportunity to grow your skills in a supportive and innovative workplace. Responsibilities Operate and monitor production equipment to ensure optimal performance. Follow standard operating procedures and safety guidelines to maintain a safe work environment. Conduct quality checks on products to ensure compliance with specifications. Assist in troubleshooting and resolving equipment issues as they arise. Maintain accurate production records and documentation. Collaborate with team members to meet production goals and deadlines. Participate in training and development programs to enhance skills and knowledge. Qualifications High school diploma or equivalent; additional technical training is a plus. Previous experience in a manufacturing or production environment is preferred. Strong attention to detail and commitment to quality. Ability to work effectively in a team-oriented environment. Basic mechanical skills and problem-solving abilities. Willingness to work flexible hours, including overtime if necessary. Good communication skills and a positive attitude.
Hot Shoppe Designs is Hiring Manufacturing / Production Team Member Hot Shoppe Designs, a custom apparel manufacturer in San Clemente, is looking for a reliable, hardworking person to join our production team. Experience is helpful, but we are willing to train the right person. If you have a good attitude, show up on time, pay attention to detail, and are willing to learn, this could be a great opportunity. This position will include working with fabric, assisting with digital cutting equipment, trimming and packaging finished garments, helping maintain a clean work area, and supporting our production team with day-to-day manufacturing tasks. Job Duties May Include: Operating and assisting with digital cutting equipment Loading and aligning fabric rolls onto cutting tables Checking finished pieces for accuracy, logos, colors, and quality Helping trim, organize, and package garments Keeping work areas and equipment clean and organized Assisting with basic machine maintenance and setup Working with the production team to complete jobs efficiently Following safety procedures and company guidelines What We’re Looking For: Reliable and punctual Strong attention to detail Willingness to learn Able to work in a busy production environment Comfortable standing for long periods of time Able to lift, push, pull, or carry up to 40 lbs. as needed Prior production or manufacturing experience is a plus, but not required English/Spanish is a plus Schedule: Monday through Friday 7:30 a.m. to 4:00 p.m. 30-minute lunch Pay: $18.50 to $20.00 per hour, depending on experience Benefits: Six Paid Holidays, Five Days Advanced Sick Time How to Apply: Please email your work experience, the city you live in, and your contact information. We are looking to hire as soon as possible. Pay: $18.50 - $20.00 per hour Work Location: In person