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Job Title: NPI (New Product Introduction) Engineer Reporting to: Carlsbad NPI Leader Location: San Jose, CA Job Site: On-Site Job Description Revision Date: May 2026 About us: We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica. Job Duties: As an integral member of the transfer team, operating under the guidance of the Project Manager, the New Product Introduction (NPI) Engineer plays a crucial role in facilitating the transition of designs into manufacturing. In close collaboration with Research and Development, Manufacturing Engineering, and Operations teams, the NPI Engineer’s key responsibilities include: • Seamless setup of components, Bills of Material (BOMs), work instructions, and procedures, including tooling and fixtures. • Ensure the timely transition of designs into manufacturing, actively supporting steady-state production. • Conduct and lead Design for Excellence (DFx) projects, optimizing cycle time, material cost, and serviceability. • Complete technical and transfer deliverables within established timelines and budget constraints. • Provide technical guidance on all aspects of short-run beta and pilot builds, including material management, documentation, resource development, and delivery. • Develop relationships with suppliers to resolve issues with single sources, high cost or lead time, and poor quality. • Design parts and modify documentation utilizing SolidWorks design tools and Product Data Management (PDM) systems. • Utilize Jira or Smartsheet in a large-scale project environment for effective communication, status updates, and milestone tracking. • Regularly communicate technical status to customers and Gener8 stakeholders. • Lead the creation, development, and implementation of test fixtures and equipment for complex electro-mechanical, fluidic, and optical subsystems. • Execute internal processes following Gener8's Quality Management System (QMS), including Engineering Change Orders (ECO), Non-Conformance Reports (NCR), Return Material Authorizations (RMA), Deviation, and Corrective and Preventive Action (CAPA) processes. • Apply problem-solving tools and lead Root Cause Analysis (RCA) activities with cross-functional teams. • Design and set up production lines, ensuring balance and efficiency using tools such as Value Stream Mapping (VSM) and process flow charts. Requirements: Bachelor’s degree in core Engineering (Mechanical, Electrical, or Industrial) with five years of experience or a Master’s degree in a core Engineering field with three years of experience. Three years of experience formulating manufacturing strategies for new product design of scientific instruments and consumables. • Three years of experience in design, structure, and engineering analysis using SolidWorks or similar tools. • Two years of experience working on large-scale multimillion-dollar projects, interfacing with Scientists, Development, Quality, and Manufacturing. • Two years of experience in direct face-to-face communication, acting as a key technical customer contact for new products being launched into production. • Two years of experience developing fixtures across different platforms, including optics, electronics, and mechanical. • Must have completed at least 3 Value Analysis/Value Engineering or Kaizen projects optimizing cycle time, material cost, or serviceability. • Two years of experience employing Jira or equivalent Kanban board system on a large-scale project to manage communication and priorities. • Two years of experience developing large-scale supply base, improving relationships and performance metrics such as cost, delivery, and quality. • Experience must include efficiency improvements in three production lines achieved by collecting and analyzing applicable data to improve cycle time. • Three years of experience in setting up and structuring complex instrument Bills of Material (BoMs), exceeding 1,000 line items in Arena or similar PDM. • Technical responsibility for at least one beta or pilot unit build process of complex instruments from start to finish. Why Join Us? We operate at the intersection of "cool science" and "precision engineering." You will be the guide of a company that builds the tools that save lives. Our Culture: We value high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the software we build matters. Message to applicants: The salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. locations, not including benefits. For non-sales roles the hiring ranges reflect base salary only. Individual pay is determined by the candidate's hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. hiring location. Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status. We are an Everify Employer and Government Subcontractor. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration. Company Benefits: Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
*Job Overview* We are seeking a dedicated and skilled Print Production Technician to join our team in a fast growing print business. While the ideal candidate would have a background in commercial printing with mechanical knowledge, with experience in printing, cutting, quality assurance, and/or shipping processes, prior industry experience is not necessary. What we are most about is high energy, dependable, a strong communicator, and with a can-do attitude professionals that can learn on the job and develop quickly. *Duties* * Work evening shifts as needed based on production demands * Duties may include: * Operate digital printers and CNC cutters * Shipping / packaging * Perform print product quality assurance and cleaning * Maintain a clean and organized work area, following safety protocols at all times. *Requirements* * Previous experience in a manufacturing facility or factory setting. * Mechanical / technical knowledge with the ability to troubleshoot print equipment issues effectively. * Familiarity with operating forklifts and other warehouse equipment is a plus. * Ability to work collaboratively in a team-oriented environment while maintaining individual accountability. * Strong attention to detail with a commitment to producing high-quality work. * Flexibility to work various shifts as needed, including overtime when required. If you are passionate about manufacturing and eager to contribute to a successful production team, we encourage you to apply for the Production Technician position today! Job Type: Full-time Pay: $20.00 - $24.00 per hour Work Location: In person
Entry Level Production Technician - (Night-Shift) Compensation: $20.00 per hour Employment type: Full-time Job title: Production Technician l Toray is a Worldwide manufacturer of high-quality water treatment products in Poway, who is seeking a motivated production assembler! This position is direct-hire, temporary, employment. We are seeking workers who can work the following shift (shift openings are based on business need/availability): Schedule: 11-hour Shift (6 pm - 6 am, with two (2) 30-minute unpaid meal breaks): Rotating Shift Schedule (Week 1 you work: Mon, Tues, Fri, Sat; Week 2 you work Sun, Wed, Thur) Requirements: An ability to read, understand, and communicate (both oral and written) in English. Basic math skills. An ability to safely use measuring and cutting tools. Good manual dexterity. Physical ability to lift, push, or pull up to 50 lbs. Awareness of the importance of attendance and good attendance records. Experience in a manufacturing environment is a plus but not required. Benefits: 100% Employer paid health care 401k with match 11 paid holidays a year PTO (Paid Time Off) and Sick time Yearly performance reviews EAP (Employee assistance programs) All candidates considered for hire must successfully complete a background check and employment health screening and must be able to maintain regular, reliable attendance in compliance with company policy. About Toray Membrane USA, Inc. Toray Membrane USA, Inc. is a worldwide manufacturer of high-quality water treatment products in north San Diego, CA. We strive to build long-lasting relationships with our employees, customers, business partners, and stakeholders. Since our establishment in 2007 in Poway, CA, as a subsidiary of Toray Industries, Inc. (founded in 1926 and headquartered in Tokyo, Japan), Toray Membrane USA, Inc. has experienced steady growth. With products backed by years of R&D and experience, such as reverse osmosis (RO), nanofiltration (NF), ultrafiltration (UF), microfiltration (MF), and membrane bioreactor (MBR) membranes manufactured in the United States, we have evolved into a critical player in Toray's water treatment business in North America, providing a solid foundation for our stakeholders' confidence in our partnership. Why work for us? At Toray Membrane, in addition to competitive salaries and outstanding employee benefits, we believe that the company's success can only be achieved with each employee's success. Supporting our employees' professional development and success is one of our high-priority missions. Employees are allowed to develop and achieve a variety of long-term career plans in a collaborative, cooperative team setting. Who are we looking for? Toray Membrane USA, Inc. seeks hardworking, accountable team players who are passionate about their work. We highly value the initiative to achieve goals proactively, the ability to collaborate with team members, and the desire to grow in your work, which could lead to a rewarding career.
We are seeking a Supervisor experienced in manufacturing, to oversee daily operations, in our water membrane manufacturing facility, located in Poway. As a Production Supervisor, you'll play a key role in leading our production teams to meet goals for efficiency, safety, and quality. This full-time position reports directly to the Operations Manager and is part of a rotating 12-hour shift schedule. Shift Available: Night Shift 6 PM – 6 AM, 12 hour shifts (2-week Rotating Shift, Week 1 you work on: Mon, Tues, Fri, Sat; Week 2 you work: Sun, Wed, Thur) Pay: $70,000.00- 85,000.00 a year Duties: Supervise daily production/assembly operations Ensure training & cross-training completion Lead by example with safety and quality focus Coordinate with other shift Supervisor and other departments Maintain accurate records for attendance and payroll Uphold Toray standards and EH&S policies Address performance issues and evaluations professionally Requirements: 3–5 years of supervision experience in a Manufacturing setting Strong leadership qualities with the ability to motivate and guide a diverse team. Excellent training development skills to nurture team members' growth. Working knowledge of Microsoft Outlook Comfortable working in manufacturing conditions Safety and other Manufacturing related certificates are not required, but preferred All candidates considered for hire must successfully complete a background check and employment health screening and must be able to maintain regular, reliable attendance in compliance with company policy. Benefits: 100% employer paid healthcare 401k with match 11 Paid Federal Holidays a year Both PTO and Paid sick leave plans Yearly performance reviews Why work for us? At Toray Membrane, in addition to competitive salaries and outstanding employee benefits, we believe that the company's success can only be achieved with each employee's success. Supporting our employees' professional development and success is one of our high-priority missions. Employees are allowed to develop and achieve a variety of long-term career plans in a collaborative, cooperative team setting. About Toray Membrane USA, Inc. Toray Membrane USA, Inc. is a worldwide manufacturer of high-quality water treatment products in north San Diego, CA. We strive to build long-lasting relationships with our employees, customers, business partners, and stakeholders. Since our establishment in 2007 in Poway, CA, as a subsidiary of Toray Industries, Inc. (founded in 1926 and headquartered in Tokyo, Japan), Toray Membrane USA, Inc. has experienced steady growth. With products backed by years of R&D and experience, such as reverse osmosis (RO), nanofiltration (NF), ultrafiltration (UF), microfiltration (MF), and membrane bioreactor (MBR) membranes manufactured in the United States, we have evolved into a critical player in Toray's water treatment business in North America, providing a solid foundation for our stakeholders' confidence in our partnership.
Location: Carlsbad, CA (Hybrid) Status: Full Time, Regular Reporting To: Creative Director About JLab JLab imagines and delivers the personal technology products that consumers want. With our line of personal audio gear and office accessories, we’re innovating absolutely everything to make way better personal tech. Based in San Diego, we’ve been offering the right sound, the right features, and the right value since 2005. JLab is proud to be a five-time winner of Best Places to Work in San Diego. Role Overview Do you love typography and layout? Do you love creating projects from creation to production? JLab is seeking an experienced Graphic/Production Designer to join our Creative team in Carlsbad, California. This role combines hands-on graphic design with strong production expertise responsibilities, supporting a wide range of packaging, marketing, retail, digital, and product launch initiatives. As a key member of the creative team, you will bring concepts to life by executing accurate, production-ready assets across print and digital channels, with occasional contributions to original design work. You will partner closely with Marketing, Product Development, Ecommerce, Sales, and international manufacturing partners to ensure all deliverables meet brand standards, technical specifications, and project timelines. The ideal candidate has strong graphic design skills, exceptional attention to detail, and a deep understanding of print and digital production workflows. If you thrive in a fast-paced creative environment and enjoy bringing products and marketing campaigns to life through both design and production excellence, we'd love to hear from you. Key Responsibilities Graphic Design & Creative Execution Master and apply JLab’s graphic standards, techniques, and style guides across all media, ensuring brand consistency Manage and execute projects from design through final production for a wide array of deliverables — including digital and print marketing assets, packaging, advertisements, email graphics, collateral, and promotional materials — delivering accurate, on-time work Create and adapt creative assets, visual concepts, and creative solutions that support marketing campaigns, partnerships, and product launches Design graphics for partner marketing initiatives, retail displays, backdrops, LED displays, and other branded experiences Recommend design and image enhancements that improve visual quality and effectiveness while maintaining brand consistency Production Design & Packaging Drive the print production pipeline for packaging, retail displays, signage, and related print materials in partnership with internal stakeholders and manufacturing partners — tracking and trafficking projects through to physical completion, including preparing production-ready artwork, preflighting, proofing, and troubleshooting files to ensure accuracy and compliance with production specifications Prepare product imagery, renderings, manuals, UPC and GTIN barcodes, and other supporting assets required for packaging and marketing execution Adapt packaging, manuals, and artwork for regional and language-specific requirements Manage artwork revisions, version control, and file distribution to manufacturing partners Ensure all deliverables meet brand standards, technical specifications, and manufacturing requirements Collaboration & Project Management Collaborate with internal stakeholders and external manufacturing partners to ensure projects are delivered accurately, on time, and to brand standards Manage multiple projects simultaneously while maintaining exceptional attention to detail and quality Contribute to process improvements that enhance production quality, efficiency, and consistency Actively contribute to marketing strategy discussions, bringing forward-thinking concepts and actionable design solutions to the table. Qualifications Minimum 5 years of experience in graphic design, production design, packaging design, or a related role. Experience working in an in-house creative department and supporting consumer products is preferred. Strong graphic design skills with exceptional attention to detail Advanced proficiency in Adobe Creative Suite, including Illustrator, InDesign, Photoshop, and XD Strong understanding of print production, packaging design trends, color management, and manufacturing specifications. Familiarity with international packaging requirements and localization workflows is a plus. Experience preparing print-ready artwork and managing prepress production requirements, including proofing, preflighting, and troubleshooting files for manufacturing Proven ability to manage multiple projects simultaneously, stay organized, and independently execute work from concept through final production while adhering to brand standards. Strong communication and collaboration skills Proficiency with Microsoft Office applications, including Outlook, Excel, Word, PowerPoint and project management tools such as Asana Applicants must be legally authorized to work in the United States at the time of hire and must maintain work authorization for the duration of their employment. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Compensation Pay Range: $31.25–$35/hour, based on skills and experience. Eligible for an annual discretionary bonus, target 5% of base salary, based on individual and company performance. Application Instructions Portfolio required. Please upload work samples or provide a link to a portfolio demonstrating your graphic design, packaging, and production design experience. Benefits & Perks, to name a few! Flexible hybrid schedule 2 weeks Work-from-Anywhere program Competitive benefits package including medical, dental, vision, and additional insurance options. Unlimited Vacation 401(k) with 4% Match Dog Friendly office Complimentary bi-monthly JLab product allotment Casual and fun workplace culture, including events and in-office happy hours Equal Opportunity Employer JLab is proud to be an equal opportunity employer. All applicants will receive consideration for employment without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, veteran status, disability, or any other protected characteristic as outlined by federal, state, or local laws. Accommodations We are committed to providing an inclusive and accessible recruiting process. In accordance with California law, we will provide reasonable accommodation to qualified individuals with disabilities to support participation in the application, interview, and hiring process.
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 Supervisor Quality Assurance manages a team of Quality Inspection personnel in the Receiving Inspection area in San Diego COGS department and a group of Quality Supports that coordinates and maintains material traceability of Nonconforming Material through the San Diego site. The supervisor organizes the tasks and requirements of the Receiving Inspection area in coordination with Logistics and Distribution management at Dexcom’s SD inbound Materials warehouse and coordinates the tasks and work plans of the Non-Conforming Material (NCMR) area. Controlling incoming materials for our manufacturing process is critical to maintaining our manufacturing schedules and high-quality standards in a high-paced environment, maintaining and continuously improving controls for nonconforming material is second nature to this role to deliver only the best product for our patients and customers. The team engages with planning, manufacturing, microbiology, supplier quality teams, R&D departments as part of daily interactions. It is a role with high visibility across the QA department but also across the entire organization. Where you come in: (target 5-8 bullets, max 10) Perform supervisory and administrative duties associated with Receiving Inspection and QA Support personnel. Coordinate tasks and work plans of the Receiving Inspection and Nonconforming Material area. Observes and verifies the accuracy and adequacy of the inspection activities and records, including activities in 1factory inspection system. Observes and verifies the accuracy and adequacy of the NCMR activities and records in IQVIA. Responsible for material flow, storage of parts, and accurate inventory transactions within the MRP system. Responsible for inventory cycle counts for Material Review Board (MRB) sub-inventory locations. Managing First Article Inspections and ad hoc inspection requirements through Jira. Maintains quality metrics and reports, as required. Identifies and implements continuous improvement projects. Writes and updates area related procedures and work instructions as necessary. Responsible for supporting inspection of engineering builds. Works across sites to ensure alignment of Receiving Inspection Activities Conducts training for personnel. Works with QA, Manufacturing, Engineering, and other department personnel, as necessary, to support quality and business objectives. Assumes and performs other duties as assigned. What makes you successful: Experience in supervision in medical device or equivalent regulated industry applying quality management systems. Understanding of 21CFR820 Code of Federal Regulations, and EN ISO 13485 Medical Devices – Quality management systems. Must have strong written and verbal communication skills. Strong interpersonal skills. A self-motivated individual, able to work in a team with minimal supervision. Able to read and understand drawings and specifications and inspection criteria and to apply criteria using appropriate and properly configured inspection tools. Understanding of acceptance sampling plans, ANSI/ASQ Z1.4, Z1.9 and C=0. Understanding of the Non-conforming Material control process in the medical device industry. Metrology systems knowledge GDT knowledge Strong computer skills desired; proficient in use of Microsoft Office and database applications. Oracle, 1factory, IQVIA, Reliance and SolidWorks experience preferred. Experience with operation of vision systems such as Keyence, OGP and Mitutoyo. Experience with Heigh Gages and CT scanners for metrology desirable. 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: 0-5% Experience and Education Requirements: 5-8 years of industry experience • Informal management/ team lead experience Typically requires a Bachelor’s degree with 6-8 years of industry experience Formal Management/team lead experienc e 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: $87,000.00 - $145,000.00
*Quality Control Supervisor (Cell Therapy products)* *Job Description: *Quality Control Manager is responsible for working closely with the Quality Assurance Director to assist in the development and maintenance of Quality Management Systems at VetStem *(Cell Therapy)*. These systems will ensure the safety, efficacy, and purity of the products manufactured by VetStem. The VetStem manufacturing facility is a state-of-the-art, GMP and GTP compliant controlled clean room facility designed to enable production of regenerative medicine products. *Primary Responsibilities: * *Develop and maintain the following systems for Cell Therapy products* * Environmental Monitoring Program management, including monitoring, trending, reporting, and coordination of EM validations. * QC assay Validations/Suitability testing (Management, Protocols and Reporting) * Management of Equipment Calibrations and OOT Response * Management of Raw Material Program (Specification development, inspection, testing and release) * QC testing (intermediate and final product release) techniques include Sterility testing, Mycoplasma testing, Endotoxin testing, Flow cytometry. Potency testing experience desirable * Maintain the stability program *Management of the Stability program for Cell Therapy products* * Deviation Management including OOS, OOT, and associated investigations, CAPAs. * Sample management and tracking program * Management of QC Record keeping and archiving *Support QA with the day-to-day management of the following for Cell Therapy products* * Reporting and organization of Quality Control test results * Issue test records and labels * Assist in review of completed records prior to filing in Records Management * Maintain technical report and change control files * Assist in deviation investigations and coordination of corrective and preventive actions (CAPA) * Write and review Standard Operating Procedures * GMP QC compliance in the manufacture of Cell Therapy products *Secondary Responsibilities for Cell Therapy:* * Support FDA inspections, internal audits from 3rd parties, and external audits, including completion of customer supplier evaluations and review of supplier agreements * Support production and manufacturing activities as needed * Assist in training staff on regulatory requirements and internal procedures as applicable * Perform additional job-related duties as required *Minimum Requirements:* * 2+ years of experience in a Quality Control/Quality Assurance role; prior experience within a cGTP/cGMP regulated biotech, cell processing, tissue bank or pharmaceutical company preferred * Demonstrated ability to manage and prioritize multiple projects and meet deadlines * Excellent time management and organizational skills * Strong written and verbal communication skills * Understanding of the fields of aseptic processing, cell therapy and cryopreservation * Exceptional analytical skills and solutions-oriented approach to problem-solving * Ability to work effectively in a fast-paced, rapidly changing environment * Demonstrated ability to work independently as well as part of an integrated team * Flexibility and dedication: Position may require some “off-standard hours” *Direct Report:* Quality Assurance Director *Minimum Years Experience: *2-5 *Travel: *none *Salary range: *$74,700.00 to $89,900.00 *Minimum Degree: BS in related field or equivalent experience. * Pay: $74,700.00 - $89,900.00 per year Benefits: * 401(k) * 401(k) matching * Flexible spending account * Health insurance * Health savings account * Paid time off * Vision insurance Application Question(s): * Are within daily commuting distance to 92064? 100% onsite * Do you have experience GMP QC compliance in the manufacture of Cell Therapy products? Work Location: In person
*Position Summary* The Certified CNC Operator / Inspector is a dual function role responsible for operating CNC equipment while also performing independent in process and final inspections on parts they did not set up. This position supports production flow by flexing between machining and quality inspection based on daily priorities. The ideal candidate is technically strong, detail oriented, and able to retain and apply inspection training consistently. _*Key Responsibilities*_ * *Must be able to read blue prints* * CNC Operation * Operate CNC mills and/or lathes according to established procedures * Perform tool changes, offsets, and basic troubleshooting * Maintain machine cleanliness and daily operator maintenance * Monitor part quality during production runs * Communicate issues with tooling, fixtures, or programs to leads or supervisors *Inspection Responsibilities* * Perform in process and final inspections on parts not set up by the operator * Verify critical dimensions using calipers, micrometers, height gages, pin gages, thread * gages, and other precision tools * Read and interpret engineering drawings, GD&T, and inspection requirements * Complete inspection documentation accurately and consistently * Support First Article Inspections (FAI) when required * Assist with receiving inspection and parts returning from outside processing * Maintain inspection equipment cleanliness and proper storage *Cross Functional Support* * Flex between CNC operation and inspection based on the daily priority sheet * Assist with calibration of shop tools and employee inspection equipment * Support NCR documentation and followup as directed * Participate in CMM training and gage R&R activities * Help with scanning, shredding, and basic administrative tasks during slow periods * Assist assembly with packaging parts when needed *Required Skills & Qualifications* * 2+ years CNC machining experience (mills, lathes, or both) * Strong understanding of machining processes, tooling, and workholding * Ability to read and interpret blueprints and GD&T * Proficiency with standard inspection tools (calipers, micrometers, height gages, etc.) * Ability to perform inspections independently and accurately * Strong attention to detail and ability to retain training * Basic computer skills for documentation and data entry * Reliable, selfmotivated, and able to work with minimal supervision *Preferred Qualifications* * Experience inspecting parts in a production environment * Familiarity with CMM operation or willingness to learn * Experience with AS9100 or ISO9001 quality systems * Prior involvement with NCRs, CARs, or quality documentation *Physical & Work Environment Requirements* * Ability to stand for extended periods * Ability to lift up to 40 lbs * Work in a machine shop environment with noise, coolant, and moving equipment *Role Expectations* * Maintain a high level of accuracy and consistency in both machining and inspection * Follow established processes and retain training without repeated instruction * Communicate clearly with machinists, leads, and supervisors * Support production flow by shifting between machining and inspection as needed Job Type: Full-time Pay: $22.00 - $34.00 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Paid time off Work Location: In person
About Carlsmed Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time. Position Description The Associate Manager, Quality Assurance supports the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and company quality standards. This role will support the Director of Quality Assurance with all quality assurance activities, including document control, audits, CAPA, nonconformance management, and continuous improvement initiatives, while collaborating cross-functionally to support product quality and regulatory compliance. The Associate Manager provides leadership and guidance to quality team members, drives quality objectives, and promotes a culture of quality throughout the organization. Key Responsibilities Support and maintain the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and other applicable regulatory requirements. Manage quality system processes, including nonconformance management, CAPA, change control, supplier management, trending analysis and quality records. Develop and update processes to improve effectiveness and efficiency. Support internal and external audits, regulatory inspections, and supplier audits, ensuring timely resolution of audit findings. Lead investigations and quality improvement activities, including root cause analysis, corrective and preventive actions (CAPA), and effectiveness verification. Monitor quality metrics and trends, analyze data, and provide recommendations to management to drive continuous improvement and regulatory compliance. Partner with cross-functional teams including Regulatory Affairs, Operations, Manufacturing, Engineering, and Clinical Affairs to support product development, manufacturing, and post-market activities. Provide leadership, coaching, and training to quality personnel and employees on quality system requirements, procedures, and best practices. Support supplier quality and risk management activities, including supplier qualification, performance monitoring, and quality issue resolution as needed. Qualifications Bachelor degree in Engineering, Life Sciences, Quality Assurance or a related technical discipline or an equivalent combination of education and relevant professional experience 5-8 years of experience in Quality Assurance within a regulated industry Strong working knowledge of ISO 13485, 21 CFR 820 and MDSAP process Direct experience with managing quality system processes such as CAPA, non-conforming products, product release and supplier monitoring Experience in supporting regulatory inspection, internal and external audits ASQ or ISO 13485 lead auditor certification preferred Effective verbal and written communication skills, including the ability to present information to management and auditors. Strong interpersonal and collaboration skills with the ability to work effectively across cross-functional teams. Demonstrated leadership, coaching, and team development capabilities. Proficiency with electronic quality management systems (eQMS), Microsoft Office applications, and quality-related software tools. Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need assistance or accommodation due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families, including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is $115,000 - $135,000. Compensation may vary based on related skills, experience, and relevant key attributes.
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. A brief overview The Quality Management Systems (QMS) Process Engineer / Sr. Process Engineer plays a critical role within the Quality Systems and Compliance team. This position is responsible for supporting the ongoing development, maintenance, and oversight of a new electronic QMS, along with transitioning from the existing EQMS, and associated Quality system processes across Bachem's U.S. sites, while also partnering with QA and other stakeholders at European locations. Additionally, the incumbent serves as a subject matter expert in electronic quality systems implementation, including but not limited to Veeva, MasterControl, LIMS, and SAP. Expected duration: This is a fulltime salaried position with full benefits. The role is primarily dedicated to supporting a quality system migration project with an anticipated duration of two years. It is expected the role will transition into the larger quality organization upon completion of project. What you will do Manage QMS system enhancement projects and collaborate locally and globally with the continuous improvement, maintenance, and oversight of the Quality Systems. Assist with Improving metrics/calculations and issuing reports to assess the health of Bachem US quality system including Global level reporting and assessment. Process mapping, Draft, and review of GMP documentation e.g. SOPs, protocols, reports Proactively develop, identifying harmonization potential and optimization of global GMP concept and quality practices within the Bachem Quality Assurance organization within the US and across international sites. Suggest and implement improvements in quality systems, policies, and SOPs taking into account LEAN GMP approaches to optimize and improve existing processes in quality. Resolve problems with GMP electronic systems and provide guidance on EQMS topics, providing hands-on support for local sites for the effective and lean implementation of these GMP processes and concepts Collaborate with QA team members and with other departments to implement improved QMS processes, systems quality culture and documentation landscape. Support GMP audits for internal operations, GMP compliance improvements and provide GMP compliance guidance to other departments and BAM Sites as needed. Qualifications Bachelor's Degree in scientific or technical discipline (chemistry, biotechnology, engineering, life sciences) Master's Degree Master's Degree (preferred) 5+ years' experience in Quality Assurance with a cGMP Manufacturing organization 2+ years' project management experience (preferred) Excellent written and oral communication skills and experience in writing standard operating procedures (SOP), and process mapping Experience with supporting/conducting audits and developing quality system metrics Comprehensive knowledge of electronic software used in quality systems (e.g. Veeva MasterControl, LIMS, SAP etc.) Ability to manage projects, organize and work in a fast-paced environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work in a team environment and interact well with co-workers, customers, regulatory agency auditors and senior management Hands-on experience with electronic system configuration (preferred) Base Annual Salary Ranges: Engineer: $82,969 - $114,083 Sr. Engineer: $103,104 - $141,768 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. Please note: unsolicited resumes from recruitment agencies will not be considered. Nearest Major Market: San Diego
Position Summary Utility workers are responsible for the essential job functions related to keeping their specific department running. Utility workers will be responsible for general duties involving physically handling products, materials, supplies and inspecting products to ensure high quality. Schedule: 3rd Shift: 9:00 PM - 5:30 AM Wednesday-Sunday Sunday-Thursday Friday-Tuesday Must be flexible to work overtime Essential Duties and Responsibilities Manual labor including but not limited to: Loading HPP torpedoes. Unloading HPP torpedoes. Standing bottles up at HPP discharge. Running the HPP dumper. Making/pre-building boxes. Bringing in fiber/packaging materials for the lines. Loading caps into cap hoppers. General labor related to the bottling process. General labor related to shipping/pack-out/receiving/inventory, etc. Building pallets, lifting, moving/stacking cases up to 50 lbs. Adhere to SOP, SSOP, GMP, and HACCP guidelines when in the plant. Ability to understand and follow verbal and written instructions related to safety, equipment operation, and daily work assignments. Regular and reliable attendance. Non-Essential Job Duties May perform similar and incidental duties as required. Experience Manufacturing experience is a plus but not required. Abilities Ability to work well under time constraints and prioritize work to meet commitments/deadlines. Ability to work cross-functional with other departments. Attention to detail and a commitment to maintaining high product quality. Flexibility to work in a fast-paced and dynamic production environment. Language Skills Ability to communicate, read, listen, and understand English. Bilingual is a plus. Working Environment Regular exposure to wet, cold manufacturing environments (temperatures as low as 35°F) Occasional exposure to dry warehouse spaces or freezer conditions (down to -10°F) Frequent exposure to high noise levels (above 85 dBA) Requires use of PPE including safety glasses, ear protection, gloves, and steel-toed footwear Physical Requirements Ability to stand and walk for the full duration of the shift Must be able to frequently lift/move hoses, equipment, and chemical containers weighing up to 50 lbs Ability to push/pull up to 100 lbs with continuous motion Must be able to bend, kneel, squat, climb stairs/ladders, and reach overhead regularly Must have sufficient hand strength and manual dexterity to operate sanitation tools and machinery Must be able to pass a pre-employment physical Why Join Suja? We’re proud to offer a competitive benefits package that supports your well-being, including: Medical, dental, vision, life insurance, and more Paid Parental Leave – 12 Weeks at 100% Pay 401(k) match to help you plan for the future Paid time off: vacation, sick days & holidays Juice benefits: yes, we keep you fueled and refreshed! Compensation $18.50/HR #INDHP Suja Life is proud to be an equal opportunity employer seeking to create a welcoming and diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, ancestry, physical or mental disability, medical condition, marital status, genetics, age, or veteran status or any other applicable legally protected status or characteristic. The Company complies with all federal/local/state regulations regarding pay Experience Preferred 1 year(s): CPG experience a plus Education Preferred High School or better Licenses & Certifications Preferred Drivers License 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.
Inicie su carrera en Builders FirstSource, el proveedor más grande de materiales de construcción, componentes de valor agregado y servicios de construcción para el mercado profesional de los Estados Unidos. Somos el número uno en nuestra industria y ayudamos a que el sueño de ser propietario de una vivienda sea cada día más fácil de alcanzar. En BFS, estará equipado con todas las herramientas, la capacitación y los recursos que necesita, y se le motivará a probar cosas nuevas, adquirir nuevas experiencias y construir una carrera con horizontes ilimitados. Bajo supervisión directa, manejar y mantener el flujo de materiales y productos en las instalaciones de acuerdo con las pautas establecidas. *Manipula físicamente materiales usados en la construcción de componentes y productos terminados para asegurar que el movimiento de dichos materiales sea óptimo: levantar, transportar y apilar productos como sea necesario. * Opera equipos motorizados y no motorizados para el manejo de materiales, algunos de los cuales pueden requerir entrenamiento especializado. Requisitos: Diploma de educación secundaria o Título de Educación General (GED). Esta es una posición de nivel inicial donde el correspondido recibirá capacitación laboral. • El trabajo es realizado dentro de un entorno de producción, sujeto a variaciones de temperatura, químicos peligrosos, partes mecánicas, niveles elevados de ruido y polvo. • Debe ser capaz de levantar y transportar hasta 25 libras frecuentemente y en ocasiones hasta 80 libras. • Se puede requerir la realización de tareas específicas que involucran escalar, levantar, empujar o arrodillarse. En BFS, queremos que usted y su carrera sean más grandes de lo que pudiera imaginarse. Nuestra cultura de apoyo en la que las personas son lo primero, lo fortalecerá y lo motivará para hacer más, ser más y ser mejor cada día. Únase a nosotros y vea todo lo que es posible cuando se enfrenta a nuevos desafíos, aprende nuevas habilidades y agrega a su banco de conocimiento profesional todos los días. En Builders FirstSource, ofrecemos beneficios competitivos y asequibles diseñados para mejorar su vida y la de sus seres queridos. Nuestro objetivo es simple - proporcionar excelentes planes que lo ayuden a usted y a su familia a tener vidas más felices, saludables y seguras. Para ver todas nuestras ofertas de beneficios, haga clic aquí www.bldrbenefits.com. Builders FirstSource es un empleador de igualdad de oportunidades/acción afirmativa. Todos los solicitantes calificados recibirán consideración por el empleo sin tener en cuenta la raza, el color, la religión, el sexo, el origen nacional, el estatus de veterano protegido o el estatus de individuo con una discapacidad. En cumplimiento de la Ley de Enmiendas de ADA (ADAAA), si tiene una discapacidad y desea solicitar un alojamiento para solicitar un puesto en Builders FirstSource, llame al (214) 765-3990 o envíe un correo electrónico a: [email protected]. No envíe currículums a esta dirección de correo electrónico; solo se debe utilizar para solicitar una modificación en el envío de una solicitud de empleo. Tenga en cuenta que, debido al volumen de aplicaciones recibidas, no podemos responder a consultas individuales sobre el estado de su aplicación.