Medical Device QC Inspector - FAI, GD&T, ISO 13485
Mevion Medical Systems Inc
Mevion Medical Systems Inc is seeking a Quality Control Inspector (Contractor) to ensure components meet stringent quality standards. You will perform dimensional, visual, and functional inspections, interpret GD&T and drawings, and document results for traceability. Ideal candidates have 3+ years in QC, familiarity with FDA/ISO 13485 environments, and experience with ERP/document control systems. This on-site role involves lifting up to 20 lbs and working in a busy production setting. #J-18808-Ljbffr Mevion Medical Systems Inc
- ...Technician in Acton, MA to support the development of innovative medical devices. You will perform inspections, review drawings, and document... ...detail, and the ability to maintain accurate records per GMP/ISO 13485. Load-bearing patient safety context with a collaborative...Suggested
- Mevion Medical Systems in Littleton, MA is seeking a Contract Quality Control Inspector to ensure incoming, in-process, and finished... ...requires 3+ years in QC and familiarity with FDA/ISO 13485 guidelines. You will perform... ...interpret drawings with GD&T, and support audits....SuggestedContract workFor contractors
$176k - $242k
...aerospace, defense, medical, and other... ...unifying our medical device product development... ...Article Inspection (FAI) protocols, and engineering... ...compliant with ISO 13485 and FDA QMSR (21 CFR... ..., complex GD&T (ASME Y14.5), inspection... ...barrier systems, and QC inspection (...Suggested- ...shop-floor QA activities, and assist audits to uphold cGMP and ISO 13485 compliance. This early-career role offers hands-on... ...manufacturing compliance, and product release activities within a regulated medical device environment. #J-18808-Ljbffr Anika TherapeuticsSuggested
- ...Senior Quality Control Inspector Littleton,... ...compliance with FDA and ISO 13485 standards, and partnering... ...Conduct First Article (FAI), in-process, final, and... ..., specifications, and GD&T symbols to verify... ...experience in Quality Control; medical device experience a plus...Suggested
$18 per hour
...to include an updated resume. Pay Details: $18.00 to $20.40 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan...Hourly payTemporary workWork at officeLocal areaShift workDay shiftAfternoon shift- ...Summary:The Quality Control Inspector (Contractor) will be... ...with FDA and ISO 13485 requirements, and the... ...article inspections (FAI), in-process inspections... ...engineering drawings, GD&T symbols, specifications... ...experience in Quality Control. Medical device inspections experience...For contractors
- ...technologically advanced, implantable medical devices for the cardiovascular, spine... ...experience preferred QC-Calc Inspection Xpert... ...MeasureMind / Zone3 / Calypso) ISO 13485 regulated environment... ...knowledge of Blue Print reading and GD&T Lowell offers a...Night shiftWeekend work
$23 - $38 per hour
...First Article Inspections (FAI) and routine part inspections... ...internal, industry (AS9100, ISO 9001, ISO 13485), and regulatory requirements... ....Extensive knowledge of GD&T principles.Experience with... ...troubleshooting.Experience in medical device, aerospace, or defense manufacturing...Hourly payShift workNight shiftWeekend work$28 - $36 per hour
...Technician at Lexington Medical, you will inspect... ...components using GD&T and OGP and... ...be the experienced inspector behind the incoming... ...process from inside QC.ResponsibilitiesPerform... ...components and finished devices per documented... ...or experience under ISO 13485 and FDA quality...Hourly payFull timeMonday to FridayDay shift$23 - $38 per hour
...aerospace, defense, medical, and other... ...Purpose As a Quality Inspector at VulcanForms you... ...Article Inspections (FAI) and routine part... ...industry (AS9100, ISO 9001, ISO 13485), and regulatory... ...Extensive knowledge of GD&T principles.... ...Experience in medical device, aerospace, or...Hourly payShift workNight shiftWeekend work$176k - $242k
...across aerospace, defense, medical, and other essential... ...of new medical device products on our high-speed... ...practices compliant with ISO 13485 and ISO 14971 and supports... ...Article Inspection (FAI), engineering change, and... ...build preparation, GD&T, and statistical process...- ...deep experience in aerospace, medical device, or other regulated... ...QMS) requirements, including ISO 9001, AS9100, and ISO 13485, as applicable to this role... ...first article inspection (FAI) requirements and approve FAI... ...skills, including advanced GD&T. • Advanced knowledge of...Full timeWork at officeMonday to Friday
- ...Help ensure the integrity of innovative medical devices from development through to delivery.... ...Cleanroom gowning and adherence to GMP/ISO standards may be required The Quality... ...documentation in accordance with GMP and ISO 13485 standards Collaborate with engineers...Contract work
- ...systems, inspection methods, and tools are used to verify product quality throughout the process. The role requires strong analytical and leadership skills, experience with ISO 13485 and 21 CFR 820, and hands-on proficiency with metrology tools. #J-18808-Ljbffr SMC Ltd.
- ...suppliers manage supplier performance conduct audits (ISO 13485, ISO 9001, FDA) lead corrective actions support CAPA... ...years in Supplier Quality or Quality Engineering, ideally in Medical Device, IVD, biotech, or pharma manufacturing strong analytical,...
- A leading medical device supplier is seeking Quality Control Analysts for night shifts in Ayer, Massachusetts. This role involves conducting accurate inspections and operating computerized inspection systems. Candidates must have a high school diploma and at least 2 years...Long term contractPermanent employmentNight shift
$160k - $175k
...Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule... ...with global standards, including FDA 21 CFR Part 820 and ISO 13485. Qualifications for the Senior Quality Assurance Manager...Full time$64.7k - $103.5k
...discipline preferred 1-2 years of software validation experience, preferably in the medical device or pharmaceutical industry but any industry knowledge is acceptable. Knowledge of ISO 13485 and FDA part 820 is preferred Knowledge/Skills Required: Excellent attention to...Local areaWorldwide- ...RESUMES FROM RECRUITERS. About Us: Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical... ...procedures and external standards and regulations, including cGMP, ISO 13485 and 21CFR Part 820. Support quality system functions such...Work experience placementWorldwide
$205k - $245k
...reagents. Candidates should bring strong leadership in complex medical device/instrumentation development, a track record of systems level... ..., including FDA Quality Management Systems Regulations, (ISO: 13485, 14971), IEC 62304 for software lifecycle processes, IEC 623...Full timeWorldwideShift work$30 per hour
Quality Technician (Medical Device Manufacturing) Location: Acton, MA Pay Rate: $30.00/hour Schedule: Monday-Friday | 9:00 AM-5:00 PM Looking... ...Maintain accurate records in compliance with GMP and ISO 13485 standards Support investigations, root cause analysis, and corrective...For contractorsLocal areaMonday to Friday- ...Quality Control Technician (Sr. Inspector) Uses a variety of technical... ...of components or finished devices according to established engineering... ...to ensure that FDA and ISO/MDD regulations are met Participate... ...a plus ~ Experience in the medical device industry with emphasis...For contractors
- ...and the executive management team to characterize and develop medical device products. This individual will perform analytical quality... ...Compliance Regulations (i.e., FDA 21 CFR Parts 58 and 820 and ISO 13485); and The willingness to assist in all necessary areas in order...Work experience placement
$27 - $31 per hour
...CMM/vision systems and precision tools per GD&T requirements. Maintain and manage... ...operating/programming CMMs. Familiarity with ISO 9001 and audit preparedness. Working knowledge... ...in semiconductor, precision machining, medical devices, aerospace, or automotive manufacturing....Hourly payFlexible hours$120k - $135k
...clients enabling them to focus on their own core competencies in Medical Devices, Robotics, and Aerospace / Defense Equipment. JOB... ...Helix, ALM, Jama, etc. Strong working knowledge of FDA QSRs, ISO 13485, IEC 62304, IEC 60601, ISO14971 requirements. Experience...Full timeFlexible hours$69.32k - $95.33k
...sustainability across aerospace, defense, medical, and other essential industries. Through... ...compliance with government regulations and ISO quality standards within an aerospace and... ...in a manufacturing and/or medical device or aerospace and defense production environment...Work at office- Title Inspector, Quality Control Location Westford, MA Duration 6 Months... ...respect to incoming material QC requirements Recommends... ...Benefits Upon Waiting Period Medical and Prescription Drug Plans Dental... ...products in diagnostics, medical devices, nutritional and branded generic...Temporary workFlexible hoursShift work
$25 - $30 per hour
...hiring a Manufacturing Quality Technician in Ayer, MA. The role requires operating and maintaining advanced automated equipment for medical device production. Candidates should have a high school diploma or GED, along with strong mechanical skills. Experience in robotics,...Hourly payContract work3 days per week$64.6k - $110k
...recognized premium supplier to the medical market with locations... ...line with the SOPs. To maintain device history records (DHR) & product... ...maintain microbial record in ISO class-7 & class-8 as per procedure... ...Working knowledge of the ISO 13485 & ISO 9001standards. FAIR...Contract workWork experience placement
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