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2 weeks ago

Quality Engineering Intern

IRP Medical - San Clemente, CA 92673

IRP Med is seeking a Quality & Engineering Intern who is currently enrolled in, or recently graduated from, an engineering program and is looking to gain hands-on experience in a manufacturing and quality-focused environment. This internship provides exposure to Quality Assurance, Manufacturing Engineering, and Continuous Improvement activities supporting our aerospace and industrial production operations. This internship runs Tuesday, 09/08/26 – end of December (12-16 weeks) and requires 20–40 hours per week. Job Responsibilities: Support Quality Assurance activities such as inspection, testing, documentation updates, and data collection. Assist in reviewing quality records, nonconformance reports, and corrective/preventive actions (CAPA). Perform basic dimensional inspections and support measurement system activities under supervision. Assist Engineering and Quality teams with process validation, first article documentation, and production troubleshooting. Participate in root cause analysis and continuous improvement initiatives (e.g., 5S, lean activities, process mapping). Help maintain and update quality documents, work instructions, and databases. Support cross-functional Manufacturing, Quality, and Design Engineering teams as needed. Learn daily operations and participate in hands-on tasks related to production and quality processes. Other engineering/quality assignments as required. Regular, consistent, and punctual attendance is required. Job Specifications: Education High school diploma/GED required. Currently pursuing a Bachelor’s or Master’s degree in: Mechanical Engineering Manufacturing Engineering Industrial Engineering Aerospace Engineering Or a related technical discipline Experience 0–2 years of engineering, quality, or manufacturing experience (internships, projects, or lab work acceptable). Skills Strong attention to detail and organizational skills. Ability to follow established processes and solve straightforward problems. Good communication skills and the ability to work collaboratively with cross-functional teams. Basic understanding of engineering principles, manufacturing processes, or quality concepts preferred. Proficiency with Microsoft Office (Excel, Word, PowerPoint). Experience with CAD, basic metrology tools, or statistical analysis is a plus but not required. IRP Med is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. Applicants requiring reasonable accommodation to complete the application process may contact Human Resources. This position requires access to information subject to the International Traffic in Arms Regulations (ITAR). Employment is contingent upon the applicant being a “U.S. person” as defined by ITAR (22 CFR §120.15), which includes U.S. citizens, lawful permanent residents, refugees, or asylees, as required by U.S. export control laws.

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2 weeks ago

Quality Assurance Inspector I

Argen Corporation - San Diego, CA 92126

Join Argen as a Quality Assurance Inspector I Location: 8515 Miralani Dr, San Diego, CA 92126 Schedule: Monday–Friday, 7:30am – 4:00pm Argen, a global leader in digital dentistry and dental materials, is seeking an HR Generalist to support benefits & LOA administration, HRIS reporting, recruiting, onboarding, and compliance. If you thrive on details, communication, and project management, this role is for you. About the Role The Quality Assurance Inspector I plays a pivotal role in ensuring the quality and integrity of Argen products. This position is responsible for inspecting in-process and finished goods within manufacturing areas to ensure compliance with ISO 13485:2016, FDA regulations, customer specifications, Argen requirements, and applicable procedures. Key Responsibilities Conduct in-process and final inspections and testing as required. Perform visual inspections of finished products. Participate in internal assessments and audits. Maintain accurate inspection and test records. Identify and properly label non-conforming materials. Communicate product/material acceptability to production personnel. Assist with technical problem-solving and special projects. Maintain lot traceability, log sheets, and housekeeping standards. Follow safety policies and regulations to ensure safe work practices. Ensure lab cleanliness and safety standards are upheld. Perform thorough inspections during and after production to ensure quality and compliance. Verify product labeling for accuracy and regulatory compliance. Clear and prepare production lines for subsequent runs. Review and validate Device History Records (DHRs) for completeness and compliance. Perform other duties as assigned. ✅ What You Bring High school diploma or equivalent required. Experience in a GMP-regulated facility is a plus. Completion of 8 hours of Quality Training (PTC) required. Strong attention to detail. Proficiency in basic arithmetic and problem-solving. Understanding of raw materials, production processes, and quality control. Familiarity with administrative procedures and computer systems. Effective written and verbal communication skills. Ability to interpret technical drawings, artwork, and procedures. Commitment to safety and quality standards. Ability to follow site protocols, policies, and procedures. Flexible, motivated, and capable of working independently. Strong organizational and time-management skills. Problem-solving abilities. Ability to learn technical concepts through documentation and training. Preferred knowledge of regulatory standards including: cGMP, ISO 13485, 21 CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16/2013, MHLW MO 169, TG(MD)R Sch3 Why You’ll Love Working at Argen Competitive pay and full benefits package Medical, dental, and vision insurance 401(k) with employer match Paid time off and wellness programs Employee events and exclusive discounts A collaborative, innovative, growth-focused culture

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2 weeks ago

Automation Technician

FlexibleAssembly Systems Inc - San Diego, CA 92126

Flexible Assembly Systems Inc based in San Diego is a machine builder specializing in custom engineered work cells with a strong emphasis on Robotics and Automation. We are currently seeking an Electro-Mechanical Assembly Technician to become an integral part of our team! You will perform various machine building tasks as well as identify areas of improvement to increase efficiency. As a constantly expanding business we are looking for a reliable, hardworking person to join our experienced and dedicated team. *Mechanical Assembly & Fabrication* * *Precision Fabrication:* Perform high-accuracy drilling, tapping, and cutting of aluminum extrusions, steel plates, and mounting brackets. * *Structural Assembly:* Expertly assemble machine frames and motion control stages using a variety of hardware (socket head cap screws, T-nuts, dowel pins) while adhering to strict torque specifications. * *Pneumatic Integration:* Install and route pneumatic lines, manifolds, and actuators, ensuring leak-free connections and proper sequence of operation. *Electrical Assembly (UL 508A Panel Standards)* * *Control Panel Integration:* Lead the layout and mounting of components within low-voltage (24VDC) and high-voltage (up to 480VAC) cabinets, ensuring compliance with *UL 508A* standards for spacing and clearance. * *System Wiring & Management:* Execute point-to-point wiring of PLC I/O, VFDs, motor starters, and safety relays. * *Wire Termination Excellence:* Mastery of crimping, ferrule application, and wire labeling to ensure long-term reliability and ease of field service. * *Precision Soldering:* Perform occasional high-reliability soldering for custom connectors, sensors, or PCB headers where standard terminations are not applicable. * *Schematic Navigation:* Flawlessly interpret complex multi-page electrical schematics and ladder logic diagrams to verify circuit integrity. *Testing & Quality Assurance* * *Cold/Hot Testing:* Conduct continuity checks and "power-on" testing to verify circuit paths and prevent component damage. * *Troubleshooting:* Identify and rectify wiring errors or mechanical interference during the initial build phase to streamline the commissioning process. * *Documentation:* Maintain rigorous red-line drawings and build-logs to capture "as-built" changes for the engineering team. *Responsibilities:* * Follow procedures, drawings, manufacturing instructions and specifications, documenting work, controlled documents. * Read engineering prints and work without the aid of written manufacturing instructions as necessary. * Troubleshoot manufacturing problems and interface with other departments in developing solutions * Work with a team to assemble entire products or components * Rotate through tasks for specific production processes * Conduct quality inspections on products and parts * Maintain a clean and orderly work area *Qualifications:* * Excellent English communication skills (Verbal & Written) * Proactive work ethic; strong people skills; positive attitude * Results driven individual with meticulous attention to detail * Proficient in Microsoft Windows based programs to include Excel, Outlook, and Word * 5 years previous manufacturing/assembly experience. * Familiarity with power tools (drills, grinders, screwdrivers, cutting tools, etc) * Quality control experience preferred * Pass required background and reference checks. * Previous experience in manufacturing, assembly, or other related fields * Ability to handle physical workload * Ability to work well in teams * Ability to thrive in a fast-paced environment * Occasional travel for installations and field support Job Type: Full-time Pay: $27.00 - $35.00 per hour Benefits: * 401(k) * 401(k) matching * Health insurance * Paid time off * Professional development assistance * Tuition reimbursement Experience: * Mechanical assembly: 5 years (Required) Work Location: In person

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2 weeks ago

Manufacturing Engineer

Fabric8Labs - San Diego, CA 92121

Fabric8Labs, headquartered in sunny San Diego, CA, is revolutionizing advanced manufacturing with next-generation 3D printing technology. We're looking for a *Manufacturing Engineer* as we scale our patented Electrochemical Additive Manufacturing (ECAM) process for global production. ECAM uses precise, room-temperature metal deposition to unlock geometries and applications that conventional metal AM can't reach. Since announcing our agreement to be acquired by TDK Corporation, we're rapidly expanding our team to advance this disruptive technology across a wide range of electronics components—including data center infrastructure, wireless communications, and power electronics. As a Manufacturing Engineer, you’ll be contributing to the company’s efforts to push the boundaries of ECAM technology by maturing our internal manufacturing processes. This will involve the guiding of the technician staff, as well as leading troubleshooting and Design-for-Manufacturing efforts as we grow and develop our fleet of internally designed and manufactured machines. Your efforts, learnings, and improvements will be leveraged across the fleet and into future fleets and machine development. This is a fast-paced, intellectually challenging position, and you’ll often have to wear multiple hats: designing, testing, supporting, and troubleshooting production processes and equipment. This position requires strong quantitative and analytical skills, critical thinking, and the ability to balance multiple projects simultaneously. We’re changing the manufacturing industry, and we want contributors who are ready to solve the technical challenges of tomorrow. The best person will be able to accept the chaos of R&D while striving to bring stability to parts and processes to make them ready for production scale. *Primary Responsibilities* * Mature internal manufacturing processes from R&D to mid volume production readiness * Improve production effectiveness through equipment, process, documentation, and training * Coordinate and perform CAD design and drawing efforts * Coordinate with other technical teams to ensure system compatibility * Excel as a team member by supporting our technician staff, collaborating with other technical disciplines and interfacing with external vendors and consultants * Hands-on assembly and troubleshooting *Minimum Qualifications* * 2+ years of experience designing, building, and supporting manufacturing lines * Experience designing assembly jigs and fixtures * Experience creating work instructions and process documentation * Bachelor’s degree in Mechanical Engineering or similar *Desirable Skills and Experience:* * Strong back-of-envelope skills to use first principles * Experience designing and improving low volume manufacturing processes * Demonstrated ability to iterate and validate changes quickly * Demonstrated hands-on manufacturing experience *Why Work at Fabric8Labs?* * We offer a comprehensive benefits package, health, dental, and vision plans; 401(k) with employer match; and an unmetered vacation policy. * We have a collaborative work environment where we work in tight-knit teams focused on transforming manufacturing technology. * Regular catered company events and celebrations, and a fully stocked breakroom! *Other information* * Routinely required to sit; walk; talk; hear; use hands to keyboard, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch. Routinely required to move around the facility. * Occasionally lift and/or move up to 40 pounds. * May require travel (domestic and/or international) dependent on business needs, up to 10% * Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. _Fabric8Labs is an equal opportunity employer. We are committed to diversity and inclusion in the workplace. Fabric8Labs prohibits discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws._ Job Type: Full-time Pay: $85,000.00 - $110,000.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Flexible schedule * Health insurance * Paid time off * Parental leave * Vision insurance Experience: * engineering: 5 years (Required) Ability to Relocate: * San Diego, CA 92121: Relocate before starting work (Required) Work Location: In person

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2 weeks ago

Production Operator

Solatube International - Vista, CA 92081

Solatube (A Kingspan Company) is widely recognized as an industry innovator which has earned acclaim around the globe for its unrivaled ability to transform interior spaces with the power of daylight. Based in Vista, California, Solatube (A Kingspan Company) designs and manufactures a full line of daylighting systems and ventilation products. To help us continue to grow our offerings, we’re searching for a Production Operator who will perform any combination of repetitive machine operations and assembly functions to produce quality tubular daylighting devices and accessories safely and efficiently. Responsibilities: Operates work-cell stations (such as but not limited to): assembly, packaging, and soldering Follows written SOP and verbal job specifications and uses knowledge gained by experience May set stops or guides as indicated by prints, diagrams, and instructions Observes machine operation to detect workpiece defects or machine malfunction Positions workpiece against stops, or aligns layout marks Pushes buttons or depresses pedal to activate machine Bolts, clips, screws, cements, tapes, or otherwise fastens parts together using hand tools And/or power tools, riveter, elbow machine and hipot tester Assist with start-up and shut-down procedures Assist with color changeovers Hanging parts on the powder coat line Removing and packaging parts for delivery Ensuring paint booth and powder coating equipment is organized and clean Assist with quarterly maintenance Works in assigned work-cell station and within various rotations as production needs require including other departments Works on line where tasks vary as different model of same article moves along line Responsible for finished good to be shrink-wrapped and staged for delivery to distribution center Meets quality control standards Cleans up work area as required Communicate effectively with peers, supervisors, and management Completes accurately all daily summary, yield cards and scrap reports as required by the Company Performs all duties safely Attends meetings and classes as required Qualifications: High school diploma or equivalent degree and/or experience. Good communication skills. Ability to be a team player. At Solatube (A Kingspan Company), we believe our employees are our greatest resource. We offer a competitive salary, benefits, and vacation package for all full-time permanent positions. Kingspan is proud to be an equal opportunity workplace and is an affirmative-action employer. #ZRKLA Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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2 weeks ago

Machine Operator

Solatube International - Vista, CA 92081

Solatube (A Kingspan Company) is widely recognized as an industry innovator which has earned acclaim around the globe for its unrivaled ability to transform interior spaces with the power of daylight. Based in Vista, California, Solatube (A Kingspan Company) designs and manufactures a full line of daylighting systems and ventilation products. To help us continue to grow our offerings, we’re searching for a Machine Operator who will perform repetitive machine operations and assembly functions to produce quality products, devices and accessories. Benefits: Full-time employees are eligible to enroll for dental, medical and vision insurance immediately upon hire. Additional offerings include pre-tax accounts for healthcare, 401k plan with a company match, PTO program, 13 paid company holidays, and on-the-job training. Motivated individuals will also enjoy growth opportunities as our company grows. Responsibilities: Operates machines (such as but not limited to): clamp, cut-to-length, manual or automatic elbow, flashing press, notch, CNC routers, stamping press, rivet, rolling, sheer, swaging, tape, vacuum form, turret punch press, press brakes, and welder. Operates workstations (such as but not limited to): assembly, packaging, and soldering. Follows written and verbal job specifications and uses knowledge gained by experience. May set stops or guides as indicated by prints, diagrams, and instructions. Observes machine operation to detect workpiece defects or machine malfunction. May make minor machine adjustments (if trained) when needed. May oversees and trains new operators in assembly work cells. Positions workpiece against stops, or aligns layout marks. Pushes buttons or depresses pedal to activate machine. Bolts, clips, screws, cements, tapes, or otherwise fastens parts together using hand tools and/or power tools. Works in all work-cell stations and all rotations as production needs require. Meets quality control standards. Cleans up work area as required. Communicate effectively with peers, supervisors, and management. Performs all duties safely. Qualifications: High school diploma or equivalent experience. Forklift operation experience helpful. Good communication, organization, and mathematical skills. Familiar with mechanical training and operation of various mechanical equipment, such as Amada Punch Press and Press Brake machinery. Ability to be a team player. Ability to lift up to 50 lbs. and remain physically active for a full shift. Availability for 1st shift hours. At Solatube (A Kingspan Company), we believe our employees are our greatest resource. We offer a competitive salary, benefits, and vacation package for all full-time permanent positions. Kingspan is proud to be an equal opportunity workplace and is an affirmative-action employer. #ZRKLA Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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2 weeks ago

Sr Process Engineer

Dexcom - San Diego, CA

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: Join our dynamic manufacturing engineering team at the San Diego Innovation Center of Excellence, where we lead development, scale up, and transfer of products, manufacturing processes, and equipment into operations, with a primary focus on advancing Dexcom Sensor technology. Responsibilities include providing day-to-day technical support for pilot plant processes and products at our San Diego site, evaluating new product and process introductions for manufacturing readiness and scalability, and leading continuous improvement initiatives to achieve operational KPIs and business objectives. The Sr Process Engineer will possess a deep theoretical knowledge base combined with strong independent thinking skills. You should excel in translating theoretical concepts into practical solutions, particularly when tackling complex problems. You will lead investigations and data analysis efforts to drive optimal solutions within a matrixed organizational structure. Where you come in: You will lead and execute process improvements for assembly products, with a focus on quality, reliability, manufacturability, and cost efficiency. You will drive structured root‑cause investigations and failure analyses utilizing analytical techniques, requiring a strong foundation in assembly engineering principles. You will collaborate with R&D, Manufacturing, Quality, and Operations Engineering to identify and implement opportunities that enhance process capability and product quality. You will support production scale-up, second-source qualification, and change control in compliance with design controls and quality system requirements. You will support New Product Introduction (NPI) activities, ensuring seamless planning, execution, design transfer, and scale-up. You will apply advanced analytical and statistical techniques (e.g., DMAIC, DOE, SPC, RCA) and drive process validation activities (IQ/OQ/PQ). You can communicate and collaborate effectively across functions You will drive strategic thinking and long term process improvements What makes you successful: Your experience driving improvement in machine performance, test methods, analytical test equipment, validation standards and manufacturing processes You use of analytical tools like Structured Problem Solving or DMAIC to drive continuous improvement You have hands on knowledge of process characterization, SPC control, DOE, and project leadership. You have a total system perspective to create high performance solutions where mechanical, electrical and software components interact with people Your flexibility in a fast-changing environment and ability to prioritize projects while maintaining timelines You are detail oriented and organized with excellent written and verbal communication skills What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . 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: 5-15% Experience and Education Requirements: Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience. 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. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. Salary: $91,400.00 - $152,300.00 #DexcomUS

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2 weeks ago

Director, Quality Audits

Dexcom - San Diego, CA

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 Compliance team at Dexcom plays a critical role in ensuring the integrity, effectiveness, and scalability of our global Quality Management System (QMS). As a key function within Global Quality, we are responsible for ensuring our products remain safe, effective, and compliant with global regulatory requirements while supporting Dexcom's mission to empower people to take control of health through innovative glucose biosensing technology. We partner across the organization to enable innovation, drive operational excellence, and maintain the highest standards of quality and compliance. As Dexcom continues to expand globally, the Quality Compliance team leads the evolution of our quality systems and processes to meet increasingly complex regulatory requirements while ensuring agility, efficiency, and scalability. Where you come in: You will: Provide strategic leadership for Dexcom's global Quality Audit program, ensuring a risk-based approach that drives compliance, operational excellence, and continuous improvement. Establish and lead a Corporate Audit program that proactively identifies, assesses, and mitigates quality and compliance risks across the enterprise. Drive global standardization and effectiveness of the Internal Audit program while partnering closely with sites and functional teams to ensure consistent execution. Ensure ongoing inspection readiness across the organization by strengthening audit capabilities, monitoring compliance trends, and partnering with key stakeholders. Build, develop, and lead a high-performing global audit organization, fostering a culture of accountability, collaboration, and continuous development. Leverage audit insights, metrics, and leading indicators to identify systemic risks, drive proactive improvements, and enhance the effectiveness of the Quality Management System. Serve as a trusted partner to cross-functional leaders, influencing strategic decisions and driving sustainable solutions to complex compliance and quality challenges. Champion a culture of quality, compliance, and continuous improvement throughout the organization. Provide executive leadership with clear, data-driven reporting on audit performance, emerging risks, inspection readiness, and strategic improvement opportunities. What makes you successful: You are a strategic Quality Compliance leader who combines deep regulatory expertise with strong business acumen, enabling you to assess complex risks, influence stakeholders, and drive meaningful organizational changes. Deep knowledge of global medical device quality and regulatory requirements, including FDA QMSR, ISO 13485, EU MDR, MDSAP, and other applicable international regulations and standards. Proven track record leading audit programs with successful outcomes and sustained compliance results. Extensive experience designing, implementing, and continuously improving risk-based audit programs in a global regulated environment. Demonstrated expertise as a Lead Auditor, with the ability to evaluate complex quality systems and identify opportunities for systemic improvement. Strong analytical mindset with the ability to leverage data, trends, and leading indicators to drive proactive risk management and quality system enhancements. Ability to anticipate evolving regulatory expectations and translate them into scalable, business-focused compliance strategies. Exceptional communication and influencing skills, with the ability to effectively engage and align stakeholders from frontline teams to executive leadership. Proven success building and developing high-performing teams while fostering a culture of accountability, inclusiveness, and continuous improvement. Experience leading global audit and inspection readiness programs across multiple sites, regions, and regulatory jurisdictions. Demonstrated ability to influence executive leaders and drive enterprise-wide quality and compliance initiatives in a rapidly growing organization. What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . 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: 15-25% Experience and Education Requirements: Typically requires a Bachelor’s degree with 15+ years of industry experience Typically, 9+ years of successful management experience in relevant industry Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). 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. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. Salary: $164,200.00 - $273,600.00 #DexcomUS

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2 weeks ago

CQV Engineer III

PM Group - Oceanside, CA

: The CQV Engineer III position is an exciting opportunity to join PM Group’s quickly growing Outsourced Technical Services(OTS) team near Oceanside, CA. Outsourced Technical Services (OTS) is an integral part of PM Group’s ability to support clients across the complete project life cycle. We have over 50 years’ industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group’s ongoing expansion in the US. PM Group is an employee owned, international project delivery firm with a team of 4,000+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners. : Performs work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS) Independently interact with client to assess and continuously reassess client needs Perform quality GAP analysis Author technical and scientific reports Demonstrates an understanding of project scope of work assigned Demonstrates an understanding of commercial aspects (hours and capital cost) of their work Delivers scope of work within budgeted hours Document development as well as testing execution to meet client qualification needs Applying the principals of good documentation practices (CGDP) Collaborate in a multi discipline team environment Perform qualification protocols and review other team members qualification documents Ensure the implementation of current good manufacturing practices (CGMP) Independently assess the qualification needs of equipment, facilities, utilities and systems Provide technical guidance to less experience CQV team members Special projects as assigned : Bachelor’s degree is required; an engineering degree is preferred 5-10 Years of CQV experience in the Pharmaceutical, Life Sciences, Biotech and/or Cell & Gene Therapy industries Factory site acceptance testing (FAT) and site acceptance testing (SAT) experience Proven experience with commissioning pre-functional checklist (PFC) development and commissioning functional performance testing (FPT) Experience working with current good engineering and current good manufacturing practices Understand client needs and provide assistance with the development of user requirements specifications (URS) and system impact analysis (SIA) Demonstrated experience working in an industry regulated life sciences environment Actively participant in the document approval process Understanding of the entire validation life cycle and change control process Experience reviewing vendor supplied documents such as submittal sheets and turn over packages (TOPs) Familiar with and understand the basics of design drawings Full understanding of all commissioning, qualification and validation (CQV) testing procedures Ability to document and execute cleaning validation procedures Knowledge of cGMP Manufacturing environments is required Good technical reporting writing skills are mandatory The ability to travel as needed for client development and project execution All of your information is confidential according to EEO guidelines. Why PM Group? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2026 business strategy. Click here to read more in our 2025 Environmental, Social and Governance Report. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future. PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know. Pay Range Disclosure: The pay range for this position is $100,000 – $130,000 annually. This range represents the base salary that PM Group reasonably expects to pay for this role at the time of posting. The actual compensation offered will depend on factors such as work location, qualifications, skills, and relevant experience. RECRUITMENT AGENCIES NEED NOT APPLY #LI-MG1

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2 weeks ago

QMS Compliance Manager – IVD cGMP

Cytek Biosciences, Inc. - San Diego, CA 92127

At Cytek Biosciences, we’re transforming the future of flow cytometry. As a global leader in spectral technology, our advanced platforms enable deeper scientific discovery, empowering researchers in academic, clinical, and biopharma labs to accelerate their breakthroughs with unmatched precision and efficiency. We’re growing fast—and we’re looking for passionate, driven individuals to grow with us. If you're ready to make an impact in a cutting-edge biotech company, this is your opportunity. The QMS Compliance Manager is a hands-on leader and change agent responsible for building, implementing, and sustaining a compliant, scalable IVD cGMP Quality Management System (QMS) across Cytek facilities. This role develops practical processes, strengthens documentation discipline, and coaches teams to confidently operate within FDA- and ISO-regulated environments. The position partners closely with cross-functional leaders to drive the transition from non-GMP to full cGMP operations, ensuring readiness for audits and long-term regulatory compliance. ESSENTIAL DUTIES AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Quality System Development & Oversight Build, implement, and maintain a compliant IVD cGMP QMS aligned with 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and applicable domestic and international regulatory requirements. Develop, revise, and manage SOPs, work instructions, forms, and process maps. Lead gap assessments and execute remediation plans across functional areas. Drive continuous improvement through audits, CAPA management, and risk assessments. Track and report key quality metrics (e.g., CAPA, NCs, audit findings) to leadership. Compliance & Audit Management Conduct internal audits and walkthroughs to verify GMP compliance. Support and participate in external audits (FDA, Notified Bodies), including front-room and back-room activities. Monitor regulatory changes and ensure QMS updates are implemented. Change Leadership & Organizational Transition Serve as a change agent guiding the organization through the shift to a fully compliant cGMP environment. Partner with cross-functional leaders to define process ownership, close gaps, and ensure operational readiness. Influence and motivate teams to adopt compliant, sustainable practices while enabling business execution. Training, Coaching & Cross-Functional Enablement Develop and deliver targeted QMS and cGMP training for Manufacturing, R&D, Quality, Supply Chain, and support teams. Coach personnel at all levels on documentation discipline, QMS expectations, and audit readiness. Foster a “quality-first” mindset through hands-on mentorship and visible leadership. Quality Operations & Daily Compliance Oversee key Quality System elements: Document Control, Change Control, Training Records, Nonconformance Management, CAPA, Supplier Quality, Internal Audits Ensure timely investigations, robust root cause analysis, and effective CAPA closure. Design Control & Product Development Support Partner with R&D and Engineering to ensure Design Controls are implemented and maintained per 21 CFR Part 820 Subpart C / QMSR, including Design History File (DHF) structure, design reviews, and verification and validation planning. Support 510(k) submission readiness activities, including Technical File compilation, design traceability, and alignment of QMS records to regulatory submission requirements. Oversee software lifecycle documentation per IEC 62304 and usability engineering activities per IEC 62366, ensuring alignment between development outputs and QMS records. Champion risk management practices per ISO 14971 across the product lifecycle, from design input through post-market surveillance. REQUIREMENTS & QUALIFICATIONS: Bachelor’s or Master’s in Engineering, Life Sciences, Pharmacy, or related field. 8+ years in a GMP-regulated environment (IVD preferred). Proven experience building and implementing QMS processes from the ground up. Deep understanding of FDA QSR/QMSR (21 CFR Part 820/Part 4), ISO 13485, ISO 14971, IEC 62304, IEC 62366, cGMP, and IVD regulatory expectations. Demonstrated success leading organizations through cGMP transitions. Demonstrated experience leading RUO-to-IVD organizational and cultural transition—including managing cross-functional resistance, establishing design control and documentation discipline in R&D-driven environments, and aligning multi-functional teams to cGMP expectations. (required) Working knowledge of Design Controls per 21 CFR Part 820 Subpart C / QMSR, including DHF structure, design verification and validation planning, risk management integration, and 510(k) submission readiness. (preferred) Familiarity with GAMP 5 principles and computer/software system validation per 21 CFR Part 11 and applicable IEC standards. (preferred) Experience with multi-site QMS harmonization across geographically distributed or international facilities. (preferred) Strong analytical, communication, training, and facilitation skills. Hands-on, execution-focused mindset; comfortable writing SOPs, running workshops, coaching teams. Experience supporting front-room/back-room activities during FDA or Notified Body audits. ADDITIONAL SKILLS AND COMPETENCIES: Quality certifications preferred (CQA, CMQ/OE, ISO Lead Auditor). Strong collaboration skills across R&D, Manufacturing, Quality, and Supply Chain. Skilled in structured problem-solving, CAPA, and process improvement. Adaptable, persuasive communicator able to gain buy-in at all levels. Thrives in fast-paced, scaling environments. Familiarity with the QMSR (21 CFR Part 4) transition from legacy QSR; experience aligning QMS infrastructure to support 510(k) or CE marking submissions. Experience harmonizing QMS processes across multi-site, multinational operations, including domestic and international manufacturing or R&D facilities. Comfort navigating ambiguity in organizational change, particularly in environments where quality ownership boundaries between QA, R&D, and Engineering are still being established. PHYSICAL DEMANDS AND WORK ENVIRONMENT: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Prolonged periods sitting at a desk and working on a computer. SALARY RANGE: Fremont, CA: $131,000 - $165,000 San Diego, CA: $115,000 - 144,000 Cytek is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.

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2 weeks ago

Skilled Woodworker

Oceanammo Spearguns LLC - San Marcos, CA 92078

*Job Overview* We seek a motivated and detail-oriented individual to join our team as a skilled woodworker. We are willing to train the right candidate on the specifications of our product. We are looking for an individual with a strong work ethic, mechanical aptitude, commitment to quality craftsmanship who loves the ocean! *Duties* * Construct spearguns for the free-diving industry. * Utilize hand and power tools for the cutting, shaping, and assembling the finished product. * Assemble the speargun from the raw material to the customized final product. * Follow production standards while adhering to safety protocols. * Maintain a clean and organized work environment throughout the project duration. *Skills* * Strong knowledge of woodworking techniques and materials is preferred but not required. * Experience with physical labor associated with woodworking tasks. * Familiarity with various carpentry skills such as cutting, sanding, and measuring. * Previous custom woodworking experience is highly desirable. * Excellent problem-solving skills with attention to detail in all aspects of work. * Knowledge of water damage restoration techniques including mold remediation and structural drying processes. * Familiarity with schematics related to electrical systems or plumbing as they pertain to cabinetry or fixture installation. * Strong understanding of construction site safety standards along with experience working on diverse construction sites or manufacturing environments. * Excellent problem-solving skills combined with the ability to read technical drawings accurately for efficient project completion. Join us if you’re passionate about woodworking excellence! We value craftsmanship that combines precision with creativity—delivering outstanding results that transform spaces and restore structures with care and expertise. If you are passionate about woodworking and possess the necessary skills to excel at this role, we invite you to apply. Join us in creating high-quality spearguns that stand the test of time! Pay: $20.00 - $26.00 per hour Benefits: * Tools provided Work Location: In person

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2 weeks ago

Composite Fabricator

Seasats - San Diego, CA 92109

Role: Composite Fabricator Location: San Diego, CA (in-office) Salary: $71,000 - $80,000 / yr + stock options, 401k matching, and other benefits Role Overview: Seasats is rapidly scaling production of unmanned surface vessels that operate for months at sea in some of the world's harshest environments. We're looking for a skilled Composite Fabricator to help build the structural assemblies that make those missions possible. This role is focused on assembling composite structures and building the boats that will cross oceans unmanned. You'll bond hulls, decks, bulkheads, mounting hardware, and structural components using structural adhesives while ensuring the process meets our quality standards. Your work will directly impact the strength, durability, and reliability of vehicles deployed around the world while maintaining Seasats' name for building reliable boats! Role Details: Some specific responsibilities may include: Bonding composite hulls, decks, bulkheads, and structural components using epoxy and structural adhesives Preparing bonding surfaces through sanding, cleaning, abrasion, and other surface preparation techniques Installing bonded inserts, brackets, mounting plates, threaded inserts, and other hardware into composite structures Reading engineering drawings, assembly instructions, and work orders to accurately build assemblies Using fixtures and jigs to ensure proper alignment and repeatability throughout assembly. Trimming, drilling, fitting, and finishing composite parts as needed to meet design requirements Inspecting bonded assemblies for quality, fit, alignment, and workmanship before final handoff Collaborating with engineering and production teams to identify manufacturability improvements and refine assembly processes Maintaining a clean, organized, and safe work environment while following material handling and safety procedures About You: You enjoy being hands on and have a keen eye for detail. Experience with hand and power tools is a must but composite experience can be trained. Whether you are a cabinet maker, carpenter, tiler, a stone mason or simply like building things in your spare time this role could be a good fit for you. Some key attributes: A team player Take pride in the work you do with strong workmanship standards Always learning and open to learning/creating new techniques Diligent in time keeping and communication Always wanting to improve and add to the manufacturing process Don't mind getting dusty with the appropriate PPE Proficient in the use of pneumatic tools, drills, grinders, and measuring equipment Looking for a supportive and growth focused work environment Due to export control requirements applicable to this position, we are only able to consider U.S. persons, as defined by U.S. export control laws. This includes U.S. citizens, lawful permanent residents, and individuals granted asylee or refugee status. In addition, it's nice (though not essential) for you to have: Composite manufacturing experience Boat knowledge Composite repair experience Formal composite training About Seasats: At Seasats, we're passionate about delivering maritime robotics solutions to redefine the maritime industry. Our primary products are unmanned surface vehicles (USVs), designed to carry sensors at sea for months at a time. Our USVs provide persistent monitoring and data acquisition to defense, scientific, and commercial customers, and have autonomously crossed both the Pacific and Atlantic oceans. After thousands of years in which the only way to gather information from the ocean was to put people on a boat, these uncrewed vessels are transforming how humanity monitors and interacts with the ocean. Here, you'll find the space and opportunity to do your life's best work. Along with your salary, you'll receive perks including: Competitive insurance (including a 99% employer-covered Gold HMO plan or other options) 401k matching up to 4% of salary Four free lunches per week An employee activity fund A pet-friendly office Unlimited/Flex PTO Hiring Notes: When applying, you'll be asked to provide a resume and answer a few screening questions. Please note that we are currently unable to sponsor employment visas, so candidates must be independently authorized to work in the United States. We appreciate diverse perspectives and life experiences, and we're committed to building a team that reflects a wide range of backgrounds. Seasats provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination of any type based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, protected veteran status, or any other characteristic protected under federal, state, or local law. We look forward to reviewing your application!

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