- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance ... + Reviewing technical reports as well as documents for Design History Files + Participating in device ...in combination device or medical device industry for each level: + Associate Quality… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Certifications: ASQ CQE preferred + Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. +… more
- Actalent (Lakewood, CO)
- …a related technical field + Minimum 6 years of experience in supplier quality engineering within medical device manufacturing, including injection molding, ... Job Description: We are seeking an experienced Supplier Quality Engineer (SQE) with a strong background in...a strong background in injection molding, blow molding, or device manufacturing within the medical device… more
- AbbVie (Pleasanton, CA)
- …have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 year of ... (QSR), ISO 13485, ISO 14971, MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes & GMP; & + working… more
- Lilly (Indianapolis, IN)
- …for people around the world. The Associate Director- Quality - Indianapolis Device Manufacturing Device Quality Control Lab is primarily responsible ... for quality control oversight of the Device Quality Laboratory. **Responsibilities:** + Provide leadership...820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL) + Regulatory inspection… more
- Zimmer Biomet (Englewood, CO)
- …in Engineering or technical discipline and 3 years of related experience + Medical device experience preferred + Process Validation experience preferred + ... innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's...+ Maintain an effective and complaint Calibration program + Design , validate and maintain quality management system… more
- US Tech Solutions (San Bruno, CA)
- …and align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design /Process ... to release, manage project schedules, mitigate risks, handle the Design History File, and align with stakeholders. + Collaborate... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... products, digital health technologies across multiple therapeutic areas + Experience with device design control processes and risk management methodologies +… more
- Merck (Salt Lake City, UT)
- … devices and combination products globally. * Experience in design controls, device risk management, medical device , complex combination product kits, ... * Experience with design verification testing * Experience in working with medical device suppliers * Experience with injection molding, device assembly,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of an off the shelf, or ... an internally designed platform medical device delivery system. + Defines detailed...partners/CDMOs. + Leads all aspects of product testing and quality assurance processes for the specific device … more