- 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
- Merck (Rahway, NJ)
- **Job Description** **Job Description** The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design ... product development, commercialization, and lifecycle management. This individual will oversee device design control activities to ensure the delivery of… 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
- Merck (Wilson, NC)
- …and robust application at the site. Experience in design controls, device risk management, medical device , combination products, prefilled syringes, ... product quality . + Lead technical investigations of medical device and combination product for commercial...+ Facilitate design and technology transfer of medical device and combination products from development… 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
- 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
- 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
- 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
- Merck (Rahway, NJ)
- …in medical device engineering, particularly in the design , manufacturing, verification, validation and associated quality and regulatory aspects ... development activities including engineering design , engineering analysis and testing, medical device design controls, risk management, test method/… more