Quality Control Inspector II - Medical Device (ISO 13485)
IPG Laser GmbH
IPG Photonics (IPG Medical) in Marlborough, MA is seeking help in quality assurance for a medical device manufacturing environment. The role emphasizes incoming inspection, documentation control, and collaboration with engineers to maintain compliance and product quality across finished goods and calibration activities. The position requires a high school diploma, familiarity with ISO13485 concepts and QMS/CMMS systems, and 1-3 years of quality experience in a regulated setting. #J-18808-Ljbffr IPG Laser GmbH
- ...future of laser technologies.IPG Medical, a wholly owned subsidiary of... ...develop innovative medical device laser solutions that make the... ....Additional training in Quality and/or a focus in medical device... ...Word and Excel.Understanding of ISO 13485, ISO 14644, and CFR 21-820....Medical deviceTemporary work
- IPG Photonics Corporation in Marlborough, MA is hiring a Quality Control Inspector II (Temporary) to support incoming inspection and... ...documentation standards while working with DHRs and CAPAs in a medical device context. The position requires solid attention to detail...Medical deviceTemporary work
- Advantage Technical is seeking a Quality Technician in Acton, MA to support the development of innovative medical devices. You will perform inspections, review drawings, and document... ...to maintain accurate records per GMP/ISO 13485. Load-bearing patient safety context with...Medical device
- IPG Photonics Corporation is seeking a Quality Control Inspector II for the Marlborough, MA area. This temporary, 2nd shift position (3-11 PM) focuses on inbound material inspection, documentation review, and supporting manufacturing with timely DHR reviews. The role requires...Medical deviceTemporary workAfternoon shift
- Repligen in Hopkinton, MA is seeking a QC Inspector I to actively participate in the ISO 9001 Quality Management System and inspect in-process and final assemblies of single-use parts at our Hopkinton facility. You will use visual inspection and measuring tools to ensure...Medical device
$19.59 - $22.77 per hour
...influence the future of laser technologies. IPG Medical, a wholly owned subsidiary of IPG... ...mission is to develop innovative medical device laser solutions that make the world a better... ...and good documentation practices Assist Quality Engineers and manufacturing personnel in...Medical deviceTemporary workFor contractors- ...Spencer Gregory HaleSupplier Quality Engineer II - External Operations ENDO... ...on Sourced Finished Medical Device (SFMD) at Boston Scientific... ...Champion: Supports Material Controls external regulatory body audits... ...quality systems experience (ISO 13485 or similar). ASQ certification...Medical deviceHourly payRemote workShift work
- IPG Photonics’ Marlborough, MA site seeks a Quality Assurance professional to drive compliance and process improvements in medical device manufacturing. You will review reports, support release of finished goods, and train QA staff while ensuring GMP and QMS standards are...Medical device
$100k
...Senior Quality Engineer Location: Devens, MA Job Type:... ...,000, annually Industry: Medical Device / Regulated Manufacturing... ...medical devices, FDA regulations, ISO standards, process validation... ...Strong understanding of ISO 13485 and ISO 14971 ~ Hands-on experience...Medical deviceFull timeTemporary workLocal area- ...About The Role The Regulatory Affairs Consultant II collaborates with cross-functional teams to support medical device product changes and secure regulatory approvals or... ..., and complaint handling. Responsible for FDA/ISO/EUMDR compliance documentation. Anticipate regulatory...Medical deviceFlexible hours
- ...Maclivaro Limited is seeking a Supplier Quality Engineer for a 12-month freelance contract in Marlborough, MA or... ...the supply chain. The ideal candidate has a strong medical device background, experience with ISO 13485 and FDA requirements, and can lead investigations while...Medical deviceContract workFreelance
- ...Overview Role: Machine Operator II Location: Marlborough, MA... ...material handling and inventory control. Maintain GMP compliance and product quality standards. Complete production... ...efforts on manufacturing, packaging, medical device, pharmaceutical, or other FDA-...Medical deviceContract workMonday to ThursdayShift workDay shift
$110k - $135k
...Description: Our client is currently seeking a Mechanical Engineer - Medical Devices to lead development of complex medical devices and subsystems... ...requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others; Qualifications...Medical deviceFull time- ...industry. What You\'ll Do Provide quality and compliance input to... ...Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities... ...’ direct R&D experience in medical device industry working with... ...of FDA 21CFR820, ISO 13485, 14971, and 11607 standards....Medical deviceWork experience placementFlexible hours
- ECI is seeking a Regulatory Affairs Consultant II to support medical device regulatory activities across client projects. You will collaborate with cross-functional teams to manage changes, prepare submissions, and ensure compliance throughout product lifecycles. The role...Medical device
$75k - $90k
...methods for verification and validation testing for medical devices and disposables in an ISO 13485 and FDA QSR compliant environment. This is a full... ...assist manufacturing procedures, machine instructions. Quality Compliance: Ensure all activities align with ISO 1348...Medical devicePermanent employmentFull time$31 - $38 per hour
...Quality Control Analyst IIThe Quality Control Analyst II role is responsible for performing environmental monitoring, RODI water sampling and testing, microbiological... ...trend evaluations in accordance with approved SOPs, ISO 14644 cleanroom controls, and the company's ISO 9001...Hourly payWork experience placementWorldwideFlexible hours$24 - $30 per hour
...actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible... ...—in all aspects of work. The QC Inspector I will be responsible for: Conduct... ...field will be considered. Familiar with medical devices, bioprocessing equipment, military or...Medical deviceHourly payWork at officeWorldwideFlexible hours- IPG Photonics, headquartered in Marlborough, MA, seeks a detail‑oriented Quality Inspector to support incoming inspection and documentation control for medical device products. The role requires basic quality experience and familiarity with ISO13485 standards. Responsibilities...Medical device
- IPG Photonics-owned IPG Medical in Marlborough, MA, is seeking a Quality role to ensure compliance with medical device standards and participate in process improvements. The candidate will perform material inspections, review DHRs, and support GMP documentation practices...Medical device
$60 per hour
...holder?Job Description5 Years of experience in medical device product verification, regulatory compliance, risk... ...and SW hazard analysis activities for Class I, II, and Class III medical devices against FDA QSR 820, ISO 13485, AAMI TIR 45, FDA Validation guidance and IEC...Medical deviceFor contractorsRelocation$74.96k - $99.32k
...Job Function Conduct product design control activities for new and sustaining... ...engineering and development of Class II electro-mechanical medical devices Knowledge of Design Controls and... ...and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 6236...Medical deviceTemporary work- Role: QC Inspector I responsible for inspection, auditing, and reporting on in-process... ...facility, ensuring conformance to quality standards within ISO 9001. Responsibilities: conduct... ...9001 environment; familiarity with medical device or bioprocessing inspection standards...Medical deviceWork at office
- IPG Medical Corporation is focused on developing... ...innovative medical device laser solutions... ...Summary The Senior Quality Engineer is responsible... ...OQ, PQ, MVP, MVR, Control Plans, Process Flow... ...in accordance with ISO 14971. Calibration... ...CFR Part 820, ISO 13485 Strong proficiency...Medical device
- Job-ID: 12191Category: Quality & Regulatory AffairsLocation: Newark, DE, United States... ...ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a... ...of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO...Medical device
- ...Repligen Corporation seeks a QC Inspector I at its Hopkinton, MA facility to perform in-process and final inspections of single-use assemblies... ...school diploma or a two-year technical degree, familiarity with ISO 9001, and proficiency with basic Microsoft Office tools. #J-18...Work at office
- Repligen Corporation in Marlborough, MA is seeking a Quality Control Analyst II to support environmental monitoring, RODI water sampling, and QC testing within ISO-classified cleanrooms. The role reports to the Quality Control Manager and requires meticulous documentation...
- We are looking for an innovative Quality Control Inspector who wants to grow with a cutting-edge... ...manufacturing company in the Aerospace/Defense/Medical Device manufacturing industries. WAIT... ..., internal, industry (AS9100, ISO 9001, ISO 13485), and regulatory requirements...Medical devicePermanent employmentContract workShift workWeekend workWeekday work
- ...hardware/software within medical electrical systems... ...entire medical device industry. Your... ...regarded as being a quality leader in the... ...failure modes/risk control opportunities for... ...EUMDR-Regulated Class II Medical Device... ...System (21 CFR 820/ ISO 13485) for the Medical...Medical deviceWork at officeWorldwideRelocation package3 days per week
$61k
...the role The Product Complaint Analyst II provides technical, reporting and analytical... ...support expertise in reviewing product quality complaints, serving as primary contact.... ...and regulatory decision models. Author Medical Device Reports (MDRs), MedWatch, Vigilance, and...Medical deviceWork at officeLocal areaRelocation package3 days per week
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