- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Manager, Medical Device Quality Assurance position on our Medical Device Sustaining Engineering QA team. This ... quality risk management principles and their application to medical device development and commercialization. The scope... quality engineering team members + Represent Regeneron's medical device QMS during regulatory inspections and… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As a Medical Device & Combination Product Quality Knowledge Management ... of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the... industry. You will support the Medical Device Combo Product Research and Development Quality … more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health ... diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality ...10 years of industry experience, including 5 years in medical device and/or combination product quality… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Quality Engineer position on the Medical Device Sustaining Engineering QA team. This position will provide Quality ... subject area and the following amount of work experience in combination device or medical device industry for each level: + Associate Quality Engineer:… more
- GRAIL (Durham, NC)
- …requires regular on-site presence (5 days a week) **Responsibilities:** + Support medical device Quality Engineering operations through expert ... area. + Minimum of 5 years of experience working within a medical device , pharmaceutical, or biotech quality management system. + Experience working… more
- Merck (West Point, PA)
- …Factor Engineering, Injection Moldings, Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems, Medical ... their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... Device Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management Systems (QMS). + 3+ years of technical program… more
- Minnesota State (St. Cloud, MN)
- …a Master of Science Degree and a Graduate Certificate credential option. Graduate level Medical Device Quality (MTQ) course instruction. To learn more about ... Degree + Minimum of ten years of applicable industry experience in Medical Device Quality Systems, Risk Management, Quality Engineering, Design… more
- Danaher Corporation (Washington, DC)
- …for medical devices and AI/ML-based software as a medical device (SaMD). + Familiarity with quality management systems and standards relevant to ... about the Danaher Business System which makes everything possible. The AI Evaluation Engineer, Device Intelligence will be a key member of the AI Product and Imaging… more
- Danaher Corporation (Washington, DC)
- …for medical devices and AI/ML-based software as a medical device (SaMD). + Familiarity with quality management systems and standards relevant to ... about the Danaher Business System which makes everything possible. The Sr. AI Engineer, Device Intelligence will be a key member of the AI Product and Imaging… more
- onsemi (San Jose, CA)
- …up a clear strategy to improve them towards customer satisfaction Solid Medical Device Quality /Semiconductor Quality /Engineering background Review ... requirements are understood and met. The position will require a strong medical device and semiconductor quality background, as it requires daily… more
- Globus Medical, Inc. (Eagleville, PA)
- …years of directly related experience, having experience in a class II or III medical device environment quality inspection is preferred, complaints lab ... inspection small components using a microscope is preferred + Experience in the medical device industry and with knowledge performing their function within the… more
- Zimmer Biomet (Norfolk, VA)
- …Degree in a technical field is required + 7-10 years of work experience in medical device quality , preferably in manufacturing environments + 5 years' ... Quality leader and Management Representative responsible for directing the quality function a medical device design and manufacturing site. Utilizes … more
- Actalent (Brooklyn Park, MN)
- …Receiving Inspection Processes, and FAIs as required Skills quality engineering, quality systems management, Medical device , Quality management ... iso 13485, iso 14971, iso standards Top Skills Details quality engineering, quality systems management, Medical device , Quality management system… more
- GE HealthCare (Cleveland, OH)
- …as a Medical Device (SaMD) + Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, ... **Desired Characteristics:** + Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design… more
- J&J Family of Companies (Cincinnati, OH)
- …priorities in a matrixed environment + Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced ... Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati,...6 years of work experience in a regulated industry ( medical device , biopharmaceutical, or pharmaceutical) or veterans… more
- Actalent (Brooklyn Park, MN)
- …Receiving Inspection Processes, and FAIs as required. Skills quality engineering, quality systems management, Medical device , Quality management ... Description Support the Quality Management System (QMS) organization. Work with design...metrics, and tools. + 5+ years' experience in the medical device industry. + Working knowledge of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of 21 CFR 820 and ISO 13485 required. + Working knowledge of international medical device quality system requirements required. + Complete understanding and ... to take evening and early morning teleconferences. **Preferred:** + MBA Preferred. + Medical Device Experience preferred + Black Belt Certification preferred. +… more
- Teleflex (Chelmsford, MA)
- …investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ... Quality Engineer 2, Product Quality Assurance...Engineering (or related technical field) * 2-5 years related ( medical device preferred) experience * Experience with… more
- System One (Lakewood, CO)
- …may have a Master of Science degree in Engineering, preferred. + Minimum 10 years' global medical device quality experience, five (5) of which have been in a ... relocation assistance Type: Direct/Permanent Start date: Immediate Overview: Our client, a global medical device company, is seeking a Senior Manager, Supplier … more