- Terumo Medical Corporation (Boston, MA)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...appropriately regarding patient safety and intended use. + Marketing, Compliance , Quality and Safety + Work with… more
- Integra LifeSciences (Braintree, MA)
- …(Biomedical or Mechanical) or related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, ... are challenging what's possible and making headway to help improve outcomes. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the… more
- Catalent Pharma Solutions (Chelsea, MA)
- …day shift.** **Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and ... **Manager, Quality Control (Clinical and Tech Transfer Team)** **Position...laboratory equipment, and staff training + Responsible for GMP compliance as related to the laboratories, equipment, and staff.… more
- Danaher Corporation (Shrewsbury, MA)
- …level program + At least 8 years relevant experience industry experience (eg GMP medical device , pharmaceutical) required + At least 5 years relevant QMS ... our Quality System + Lead or support quality and compliance projects as requested, and...offer comprehensive package of benefits including paid time off, medical /dental/vision insurance and 401(k) to eligible employees. Note: No… more
- Integra LifeSciences (Boston, MA)
- …required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality /Regulatory Compliance , or other cGMP regulated product ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … more
- Sanofi Group (Cambridge, MA)
- …this role, you'll be at the forefront of innovation, combining your expertise in medical device patents with advanced AI-driven patent tools. You'll work closely ... to get started? **Main responsibilities:** + Draft and prosecute high- quality patent applications for medical devices and...Stay abreast of the evolving legal landscape related to medical device IP and AI in patent… more
- Amgen (Cambridge, MA)
- …various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key ... years of progressive experience as an engineer or scientist in relevant fields ( medical device development, manufacturing, etc.) + Proven track record of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process. + ... guidance. + Driving and overseeing User Research strategy in compliance with Quality Management System. + Developing...Preparing documentation to support medical device and combination product development activities… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Support the optimization of design control elements to comply with combination produce/ medical device regulations. Lead or assist in deviation, complaint and ... and 7+ years preferably within the biopharmaceutical industry or medical device development and commercialization are desired.... device design control process evolution to meet device regulations. + Collaborate with Quality , Mfg,… more
- Fresenius Medical Center (Waltham, MA)
- …and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on requirements to product ... work experience. + Experience should include effective interaction with manufacturing, quality , clinical/ medical and marketing departments. + Prior 510(k)… more