- Candela Corporation (Marlborough, MA)
- …monitor test results and defects, and generate final traceability reports, in compliance with design controls and all regulatory requirements. . Address ... activities in an FDA regulated environment that meets internal quality requirements and regulatory standards for Class I/II medical devices (FDA 21 DFR 820.30,… more
- J&J Family of Companies (Danvers, MA)
- …of 5 years of experience in equipment engineering, preferably in the medical device manufacturing industry. + Extensive experience with production manufacturing ... and preventative maintenance on manual and semi-automated equipment to ensure compliance with industry standards and regulatory requirements. + Mentor… more
- J&J Family of Companies (Danvers, MA)
- …of role responsibilities **Preferred Qualifications:** + Master of Science degree + Medical Device product development experience + Knowledge in medical ... + Apply biomedical, mechanical, and electrical engineering principles to develop medical devices (Impella pump and system). + Lead and contribute to… more
- Guidehouse (Boston, MA)
- …Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device , and diagnostic companies develop custom solutions that tackle ... provides commercialization strategy and reimbursement services to pharmaceutical, biotechnology, medical device , and diagnostics companies. Our client services… more
- Danaher Corporation (Waltham, MA)
- …experience, ideally with a combination of law firm and in-house roles in the medical device , pharmaceutical, or life sciences sector. . Strong contract drafting ... provides legal guidance on a wide range of commercial, compliance , and regulatory matters, with a particular...to eligible employees, including: * Paid time off * Medical , dental, and vision insurance * 401(k) retirement plan… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... with a Master's degree. + Minimum 8 years of medical device industry experience in a clinical...held religious belief or other legally required exemption._ _In compliance with the ADA Amendments Act, should you have… more
- Cognizant (Boston, MA)
- …cross-functional teams developing, and supporting information systems in the Medical Device and pharmaceutical manufacturing industries Understand the ... deep understanding of business processes under GxP, ISO, and regulatory compliance Knowledge of Mfg. Process Controls...of Electronic Lot History Records using Camstar Software for Medical Device / Pharma industries Implement and execute… more
- Altium Packaging (Turners Falls, MA)
- …to account for raw materials. Essential Duties & Responsibilities: + Ensure compliance with corporate and plant safety standards and with applicable laws and ... regulations issued by regulatory agencies + Load trucks and secure product in...materials onto or off of pallets, skids, or lifting device + Monitor material usage on work floor and… more
- Teradyne (North Reading, MA)
- …recommendations to internal Hardware/Design teams. + Interface with external labs and regulatory bodies as needed during compliance projects. + Prepare Test ... powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device… more
- Catalent Pharma Solutions (Chelsea, MA)
- …testing is conducted in line with the appropriate expectations, guidelines and/or regulatory test standards. **This is a full-time on-site salaried position: Monday ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The… more
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