- Takeda Pharmaceuticals (Lexington, MA)
- …OBJECTIVES/PURPOSE 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
- Merck & Co. (Rahway, NJ)
- …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
- 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
- GE HealthCare (Cleveland, OH)
- …Software 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
- 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… more
- Globus Medical, Inc. (Audubon, PA)
- …be an advantage but not essential Minimum of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in ... Body inspections Experience in product quality assurance, process quality , verification and validation Experience with electro-mechanical medical devices,… more
- J&J Family of Companies (Cincinnati, OH)
- …simultaneous priorities in a matrixed environment Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and ... 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
- 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...in Engineering (or related technical field) 2-5 years related ( medical device preferred) experience Experience with statistical… more
- J&J Family of Companies (Cleveland, OH)
- …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
- Curtiss-Wright Corporation (Newtown, PA)
- …industry, is preferred. Knowledge and understanding of government, military, defense and/or medical device quality standards. Experience in manufacturing ... Quality Systems Document Control Specialist The Quality...of prior related experience within the aerospace and defense, medical , or other regulated industry including transferrable military experience… more
- GE HealthCare (Cleveland, OH)
- …Software as a Medical Device (SaMD) Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, ... MDSAP. Desired Characteristics Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design… more
- Takeda Pharmaceuticals (Lexington, MA)
- …including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are ... Job Description About the Role As Head of Global Quality Device Compliance for the US and...including stand-alone devices, combination devices, and Software as a Medical Device for the US and Rest… more
- ManpowerGroup (St. Paul, MN)
- …Technician, you will be part of the Quality Assurance Department supporting the Medical Device Quality team. The ideal candidate will have strong ... compliance Providing quality assurance engineering support for marketed medical device products Handling customer complaints, supporting stability studies,… more
- Fortive Corporation (Cleveland, OH)
- …people development. Strong business acumen, communication, and strategic thinking. Experience in medical device quality assurance or biomedical engineering ... key marketing and business objectives for the Global Equipment Quality Assurance business. This includes involvement in setting strategic...Experience in software as a medical device . Fortive Corporation Overview Fortive's essential… more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …including an understanding of medical device operations (eg, medical device manufacturing, process development, quality assurance) Leads development ... experience in engineering or Quality engineering experience within the medical device , pharmaceutical, or equivalent industry Knowledge and Skills: Required… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJ ob description This position will be responsible for leading and implementing medical device and combination product design controls for both new ... a culture of operational excellence Ensure processes align with regulatory requirements for medical device and drug combination products (eg, FDA 21 CFR Part… more
- Aptyx (Charlotte, NC)
- Position Overview We are seeking a Medical Device Engineer with strong experience in the design and development of complex steerable catheters. This role is ... engineering, or a related field. Three or more years of experience in interventional medical device development, with preference for at least five years of… more
- Aptyx (Charlotte, NC)
- …- High School Diploma or equivalent experience 2-5 years inspection experience ( medical device experience preferred) Computer experience and proficiency required ... Job Description: Quality Inspector I Position: Quality Inspector...Maintain identification of materials, tools, and procedures as the device is inspected Work overtime as required Perform line… more
- Abbott (Minnetonka, MN)
- …FDA and TUV regulations, and other relevant clinical/regulatory requirements. Class III or II medical device background in a Quality Leadership role. ... 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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