Quality Leader - Medical Devices (FDA/cGMP)
Phillips Medisize
Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our manufacturing site in Costa Mesa, California. You will create value by stewarding Quality with your background in medical device quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.You will lead a team, support day-to-day manufacturing operations, manage FDA inspections, drive improvement, and ensure compliance with cGMP #J-18808-Ljbffr Phillips Medisize
- ...Irvine, California, United StatesCompany: Edwards LifesciencesPosted: 2026-08-17Edwards Lifesciences Irvine facility is seeking a Quality Senior Supervisor to lead inspection teams across components, tissue, solutions, preliminary packaging and valve assembly. You will...QualityMedical device
$100k - $135k
...seeking a contribution-motivated Quality Manager to join our... ...Quality with your background in medical device quality assurance, a passion... ...improvementEnsure compliance with cGMP, and regulatory... ...identificationProven expertise in managing FDA inspections, audits, and...QualityMedical deviceFlexible hours$109k - $174.8k
...and PMA submissions for class II and III medical devices.Conduct submission negotiations with the... ...Affairs, Submission Preparation, FDA DeviceLaw/Regulations, Worldwide Regulatory... ...and Negotiations.Strong knowledge of FDA Quality System Regulation and ISO 13485 Standard...QualityMedical deviceFull timeTemporary workLocal areaWorldwide- ...with entrepreneurs and industry leaders to launch and scale... ...overcome previously impossible medical challenges, bringing hope and... ...biopharma research, medical device innovation, AI model training... ...half with a repeatable, high-quality process. Acquired entities...QualityMedical deviceRemote work
$191.2k - $286.8k
...Medtronic is a global leader in healthcare technology... ...developing innovative medical technologies that improve... ..., regulatory affairs, quality, research and development... ...health and connected-device initiatives, advising digital... ...and standards (e.g., FDA pre- and post-market...QualityMedical deviceFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$34 - $44 per hour
...Quoting Team Supervisor serves as a key leader of the Quoting department under the direction... ...on delivery and details to ensure high-quality service and operational excellence.... ...of quoting experience, preferably in the medical device industry. ~1+ years of experience as a...QualityMedical deviceFull timeWork experience placementWork at officeLocal areaMonday to FridayAfternoon shift$120k - $140k
...20% About Kardion Kardion is a medical device company advancing innovative technology... ...collaboration with cross-functional partners in Quality, Regulatory, Clinical, R&D, Finance, and... ..., including working knowledge of FDA and TÜV requirements for medical devices...QualityMedical deviceFull time$121k - $171k
...design direction for a significant product area and ensure design quality and consistency across its features. Lead design systems... ...Factors Engineering (HFE) contributor for Software as a Medical Device, partnering with research & development, quality, regulatory,...QualityMedical deviceFull timeWork experience placementRelocation package- ...Huntington Beach, California, is looking for a Quality Inspector to join their groundbreaking... ...hands-on role requires expertise in FDA-regulated production and includes... ...have IPC certifications, experience in medical device environments, and a strong understanding...QualityMedical device
- BiVACOR in Huntington Beach is seeking a skilled Quality Inspector to contribute to the production of innovative medical devices. Your role will involve inspecting PCBAs and... ...electrical tests to ensure compliance with FDA regulations and IPC standards. A successful candidate...QualityMedical device
- ...compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more You... ...and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA... ...regulatory strategy creation design control cGMP/Quality Systems and import/export requirements...QualityMedical device
$120k
...consulting, ensuring the highest standards of quality and reliability for sensitive... ...of experience in Biopharmaceuticals, Medical Device Industry (specifically Cell & Gene... ...using DQ, IQ, OQ, and PQ.Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred...QualityMedical deviceWork at office$19 per hour
...Medical Device AssemblerLocation: Irvine, CA Hours: 5:00 AM to 1:30 PM | Pay: $19 per hourResponsibilitiesProduce high-quality medical devices within a manufacturing cell.Perform assembly, repair, and test operations on pacemakers, ICDs, leads, and related medical device...QualityMedical device$21 - $24 per hour
...Medical Device AssemblerEastridge Workforce Solutions is hiring several long-term temporary employees for a leading medical manufacturing... ...products throughout the manufacturing process to ensure they meet quality standards.Perform visual, dimensional, and basic electrical...QualityMedical deviceHourly payTemporary workLocal areaMonday to Friday- ...and cost‑effective operations. This position supports production of Class II/III medical devices and biologic grafts, requiring deep attention to traceability, quality standards, and FDA/ISO compliance. Key Responsibilities Evaluate, select, and manage suppliers based...QualityMedical device
$28 - $34 per hour
A medical technology company based in Huntington Beach, CA is seeking a hands-on individual to assemble, test, and package medical devices. Candidates should have prior experience in manufacturing, exceptional... ...and a commitment to safety and quality. This role offers competitive...QualityMedical deviceHourly payFull time$55k - $75k
...support the assembly and testing of ultrasonic nebulization devices. The role involves hands-on assembly, maintaining process control, and ensuring product quality. Candidates should have experience in medical device manufacturing, familiarity with cleanroom protocols,...QualityMedical deviceFlexible hours$20 per hour
...Job Description We are looking for a Medical Device Assembler to work in Irvine. If you have... ...safe work area. You will follow safety, quality, and cleaning rules while making products... ...preferred. ~ Experience working under FDA, GMP, or ISO rules is preferred. ~ Good...QualityMedical deviceTemporary workLocal areaShift workDay shift$19.5 - $21.5 per hour
...Medical Assembly TechnicianOur client, a leading organization in the medical device manufacturing industry, is seeking a Medical Assembly Technician to join their team. As... ...precision and carePerform product testing to ensure quality standardsPackage finished products for...QualityMedical deviceWeekend work$90k
...NAMSA Job OpportunityNAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products...QualityMedical deviceWork experience placementLocal area- ...Summary The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn’s pharmacy,... ...regulations related to pharmaceuticals, medical devices, and controlled substances. Key Responsibilities... ...83s or warning letters Coordinate with Quality Assurance on SOP compliance, change...QualityMedical device
- ...ensuring validation activities are completed in accordance with quality-system requirements. Key Responsibilities Lead and execute... ...a regulated manufacturing environment, preferably within the medical device industry. Strong technical writing, documentation, and...QualityMedical device
$19 - $20 per hour
...am - 5:30pm Summary/Objective: Medical Device implant manufacturer in Irvine is seeking... ...ability to produce consistently high-quality results while using a microscope in a cleanroom... ..., Good Manufacturing Practices, and FDA regulations including compliance to EN...QualityMedical deviceContract workTemporary workLocal areaShift workWeekend work$19 - $21 per hour
...for pay Summary/Objective: Medical Device implant manufacturer in Irvine is seeking... ...ability to produce consistently high-quality results while using a microscope in a cleanroom... ..., Good Manufacturing Practices, and FDA regulations including compliance to EN...QualityMedical deviceContract workTemporary workLocal areaShift workDay shiftAfternoon shift$19 - $21.5 per hour
...Job Description Job Description Medical Device Assembler I – Irvine, CA Contract-to-Hire... ...detail, and the ability to produce high-quality work in a fast-paced manufacturing environment... ...Good Manufacturing Practices (GMP), FDA regulations, ISO 13485 standards, and...QualityMedical deviceContract workTemporary workLocal areaShift workWeekend workDay shiftAfternoon shift$118k - $159k
...insights, making the Group a world leader in engineered polymer... ...Industrial Solutions, Trelleborg Medical Solutions, and Trelleborg Sealing... ...leaders, process owners, quality, manufacturing, engineering, and... ...Experience with manufacturing, medical device, life sciences, or another...QualityMedical deviceWork at officeMonday to Friday3 days per week$163.4k - $322.1k
...supply chain, manufacturing, quality, and procurement while also shaping... ...& Health Care practice. Our leaders work side-by-side to... ...procurement for biopharmaceutical, medical device, and broader life sciences... ...Good Manufacturing Practice (cGMP) life sciences environmentExperience...QualityMedical deviceStart working todayLocal areaFlexible hoursShift work$89.4k - $148.9k
...Flexibility: OnsiteWhat You Will DoSupport the ongoing manufacturing of medical devices by designing, documenting, and improving manufacturing processes and operations that ensure product safety, quality, and performance.Lead process qualification, verification, and...QualityMedical deviceFull timeFor contractors- ...implantable heart valve products.Partner with R&D, Quality, Clinical, and Regulatory teams throughout... ....Team LeadershipEnsure compliance with FDA, OSHA, and internal quality requirements for Class III medical devices.Manage employee performance, training, and development...QualityMedical device
$84k - $105k
...closely with Manufacturing, Quality, Supply Chain, and Warehouse... ...ERP transactions comply with cGMP requirements and internal quality... ...working knowledge of cGMP, FDA, and regulatory expectations... ...as pharmaceutical, biotech, medical device, or CDMO. Working knowledge of...QualityMedical deviceFull timeMonday to FridayWeekend work
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