- 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
- 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
- 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
- Astrix Technology (Red Bank, NJ)
- ** Quality Operations Specialist I - Medical Device ** Manufacturing Red Bank, New Jersey, US + Added - 05/02/2025 Apply for Job Our client is a Medical ... medical devices (eg MDRs, Vigilance reports, etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA… 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
- 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. (Audubon, PA)
- …an advantage but not essential + Minimum of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in ... At Globus Medical , we move with a sense of urgency...quality , verification and validation + Experience with electro-mechanical medical devices, including software, is desired + ASQ Certification… more
- Edwards Lifesciences (Irvine, CA)
- …applied sciences). + 6 years of experience in medical device engineering or medical device quality roles. + Travel required ~15%. **What else we look ... complex, hybrid projects, mentor emerging talent, and drive digital quality excellence across our medical device...and drive digital quality excellence across our medical device portfolio. Your expertise will ensure… 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
- 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
- Edwards Lifesciences (Draper, UT)
- …will manage Quality Engineers that focus on supporting Metals Operations, ensuring medical device quality compliance and that controls are in place ... lasting solutions for unmet patient needs. Our Senior Manager, Quality Engineering position is a unique career opportunity that...Belt/Lean Black Belt + Proven project management, leadership and medical device audit leader skills + Proven… more
- Abbott (Minnetonka, MN)
- …their impact on their business unit. **Preferred Qualifications** . Prior experience in the medical device industry and/or quality systems. . Strong working ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and relevant experience. **Knowledge and Skills** + Applied knowledge of the FDA medical device quality system regulations and international quality ... product development and product maintenance through the application of Quality Engineering skills for medical devices. This...the application of Quality Engineering skills for medical devices. This person will handle projects and tasks,… more
- J&J Family of Companies (Chicago, IL)
- …while professionally representing the company. + Comply with all corporate compliance, FDA, medical device , quality standards and ethics. + Other duties ... portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and… more
- TriMas Corporation (Denver, CO)
- Job Summary: The Quality Engineer collaborates closely with customers and engineering teams to define product requirements, ensuring seamless communication of these ... specifications to production. They oversee quality system performance, investigate concerns, and implement preventive actions and process improvements. Additionally,… more
- Abbott (Sylmar, CA)
- …technical areas. + Experience working in a regulated quality system environment. Medical device quality experience preferred. + Proven leadership in ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
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