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
- Mevion Medical Systems in Littleton, MA seeks a Quality Control Inspector (Contractor) to ensure incoming, in-process, and... ...standards. The role involves GD&T interpretation, FAI, and extensive documentation... ...support compliance with FDA/ISO 13485. As a key member of Manufacturing...SuggestedFor contractors
- Mevion Medical Systems, Inc. is seeking a Quality Control Inspector (Contractor) at our Littleton, MA location. The role focuses on ensuring incoming, in-process,... ...components meet stringent quality standards, with strong GD&T and inspection-methods proficiency. Travel and...SuggestedFor contractors
- Intertek is seeking an experienced Medical Device Auditor to lead and participate in 3rd party audits across multiple sites. The role requires... ...in the United States. You will assess management systems for ISO 13485 compliance, train junior auditors, and interface with...SuggestedRemote jobNight shift
- 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
- SRG is seeking a Quality Control Inspector to join their innovative team in Acton, Massachusetts. This role... ...should have 5+ years of experience in medical device or aerospace manufacturing, with strong knowledge of GD&T principles and experience with advanced inspection...SuggestedPermanent employmentContract work
- ...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
$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$23 - $38 per hour
...aerospace, defense, medical, and other... ...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 defense...Hourly payShift workNight shiftWeekend work- ...technologically advanced, implantable medical devices for the cardiovascular, spine... ...experience preferred QC-Calc Inspection Xpert... ...MeasureMind / Zone3 / Calypso) ISO 13485 regulated environment Good... ...knowledge of Blue Print reading and GD&T Lowell offers a...Night shiftWeekend work
- ...innovative Quality Control Inspector who wants to grow... ...Aerospace/Defense/Medical Device manufacturing industries... ...knowledge of GD&T principles; skilled... ...Article Inspections (FAI), Test Method Validation... ...internal, industry (AS9100, ISO 9001, ISO 13485), and regulatory...Permanent employmentContract workShift workWeekend workWeekday work
- ...all testing - visual, functional, safety, burn-in using approved standard operating procedures in compliance with Medical Devices Quality Systems, ISO 13485 and other activities as required. • Maintenance of quality records. • Maintenance of test fixtures and test instrument...
- ...Bedford, MA, is seeking a Quality Engineer II to support QA/QC for implantable medical devices. You will lead day-to-day quality activities, participate in design controls, and ensure compliance with cGMP, ISO 13485, and 21 CFR Part 820. You will collaborate with...
- ...to lead and transform the medical aesthetics industry. We are... .... Oversight on local QC team. High visibility role... ...Control team including QC Inspectors, Doc Control Quality Analyst... ...development within FDA and/or ISO 13485 regulated medical device setting, with hands on...Contract workLocal area
- ...is looking to bring on a Mechanical Inspector. This is a 1st shift direct hire... ...drawings, schematics, blueprints, and GD&T specifications to ensure accurate... ...with ASME codes & standards and ISO 13485 requirements for medical device manufacturing. Collaborate with manufacturing...Temporary workDay shift
$40 - $50 per hour
...production, radiopharmaceutical workflows, and medical device quality systems. Key Responsibilities... ...with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain to ensure... ...(21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485). Demonstrated ability to investigate...- ...respect to incoming material QC requirements. Recommends changes... ...First Article Inspections (FAI). Performs testing and... ...Benefits Upon Waiting Period: ~ Medical and Prescription Drug Plans... ...products in diagnostics, medical devices, nutritional and branded...Temporary workFlexible hours
- ...Quality Control Inspector Perform inspection of incoming materials, components, and... ...with sampling plan. Understanding of ISO 13485, CFR21-820, ISO 14644-1, 2 and 3. Able... ..., and other electronic systems. Medical device experience is a plus. Experience working...For contractorsWork at office
$73.1k - $120.2k
...Conduct supplier and internal audits to verify compliance with ISO 13485, ISO 9001, MDSAP, and applicable regulatory requirements.... ...Experience in a regulated manufacturing environment, preferably Medical Device, IVD, Biotechnology, or Pharmaceutical industries....Full timeTemporary workInternshipWorldwideFlexible hours- ...Engineer to oversee product quality, transfer to contract manufacturers, and drive continuous improvement within a FDA/ISO 13485 environment. You will lead QC activities, support CAPAs, and collaborate with suppliers and manufacturing to ensure compliance and robust quality...Contract work
- ...What You'll Do The QC Analyst II performs analytical chemistry testing and laboratory... ...within regulated pharmaceutical and medical device environments. How You'll Contribute... ...industries. • Demonstrated knowledge of GMP and ISO regulatory requirements. • Hands-on...Full timeImmediate start
$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- 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
$75.41k - $103.69k
...supports sustainability across aerospace, defense, medical, and other essential industries. Through our... ...+ years\' experience working in the medical device or aerospace fields with experience in FDA regulatory requirements, ISO 13485, and/or AS9100/ISO9001 Experience in...- ...AboutUs: Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary... ...procedures and external standards and regulations, including cGMP, ISO 13485 and 21CFR Part 820. Support quality system functions such as...Work experience placementWorldwide
- ...positioned competitively to lead and transform the medical aesthetics industry. We are guided by our... ...regulatory information to Production, QA, QC and R&D departments and senior management... ...Knowledge of US and international medical device regulatory requirements. Experience...Worldwide
- ...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
$130k - $145k
...Production Manager for our customer, a medical technology manufacturer developing and producing... ..., preferably within medical devices, capital equipment, aerospace, defense,... ...a regulated quality system, preferably ISO 13485 or FDA 21 CFR Part 820, with knowledge...Permanent employmentFull timeWork at office$70.4k - $105.65k
...feasibility procedures and other GMP/ISO standards, as necessary then... ...Design History File (DHF) and Device History Record (DHR)... ...Quality System Regulations, ISO 13485, GMP requirements, and applicable... ..., risk management, and medical device quality systems. Familiarity...Full time$61.3k - $122.7k
...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000... ...designs comply with medical device standards (e.g., IEC 60601, ISO 13485, ISO 14971). Develop project plans, change requests,...WorldwideShift work$113.6k - $156.2k
...sustainability across aerospace, defense, medical, and other essential industries. Through... ...manufacturing, aerospace, defense, or medical device manufacturing environments. Hands-on... ...in a regulated environment (AS9100, ISO 13485, NADCAP). CPSM, CPM, or equivalent professional...
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