- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Master's degree preferred. + Minimum of 8 years of experience in Quality Assurance within the medical device industry, with at least 2-3 years ... a **maker of possible** with us. **Job Summary:** The Quality Manager - Design Assurance will lead...Assurance . + Extensive knowledge and practical application of medical device regulations and standards, including FDA… more
- Integra LifeSciences (Mansfield, MA)
- …knowledge of DFSS techniques * 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development * Fluent ... new standards of care. This **Staff Design & Reliability Assurance Quality Engineer** is a key functional...Risk Management (ISO 14971 2019), MDD ( Medical Device Directive), IEC 62366, ISO 13485 ( Quality … more
- Danaher Corporation (Waltham, MA)
- …or a related field. + Experience: Minimum of 5 years in quality assurance within the medical device or related industry. + Leadership Experience: ... agile and above all audacious so we can truly drive science forward. The Quality Assurance Manager is responsible for overseeing an ISO 9001 certified … more
- 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...applications of Quality Assurance and Quality Risk Management in the medical … more
- Integra LifeSciences (Braintree, MA)
- …Mechanical) or related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or ... treatment pathways to advance patient outcomes and set new standards of care. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for… more
- Actalent (Watertown, CT)
- …repeatability of the results. Essential Skills + Quality engineering + Quality assurance + Audit + Medical device expertise + CMM programming + GD&T ... Job Title: Quality Engineer For immediate consideration, please email resume...all testing processes and product developments comply with relevant medical device regulations such as FDA (21… more
- Integra LifeSciences (Plainsboro, NJ)
- …preferred + Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. + Demonstrates ... and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical...and surveillance audits and customer audits. + Perform other Quality Assurance and Quality Engineering… more
- GE HealthCare (Cleveland, OH)
- …**Desired Characteristics:** + Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, ... 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical ... Device (SaMD) + Demonstrated understanding of Medical Device Quality Management System… more
- Envista Holdings Corporation (Quakertown, PA)
- …+ High school diploma or equivalent plus 3 years of experience working in a quality assurance , medical device and/or manufacturing setting or associate ... quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open...and Quality Systems in a regulated industry ( medical device or pharmaceutical area). + Ability… more
- Abbott (Alameda, CA)
- …8-10 years of experience in Quality Systems, Regulatory Affairs, or Quality Assurance within the medical device industry. * At least 5 years of ... Events Group (MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory reporting for Abbott's… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Master's degree preferred. _Experience:_ + Minimum of 5 years of experience in Quality Assurance within the medical device industry. + Minimum of 3 years ... **Job Description Summary** The Quality Manager will lead and oversee all aspects...CFR Part 820 (QSR), MDR, and other relevant global medical device regulations. + Proven experience in… more
- Kelly Services (Janesville, WI)
- …technical leadership. Preferred Qualifications: Experience working within a nuclear quality assurance program or medical device QMS. Familiarity with ... Senior Mechanical Engineer - Regulated Industry Focus Location: Janesville, WI Industry: Medical Device and Nuclear Direct hire, permanent, benefits from day 1… more
- Globus Medical, Inc. (Audubon, PA)
- …required (science or engineering preferred) + 3-5 years' experience in quality assurance ; experience in the medical device industry preferred + GMP ... maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. As a contributor to the quality… more
- Teleflex (Olive Branch, MS)
- …ASQ Certified Quality Engineer certification. * 3+ years of Quality Assurance experience required within medical device / FDA regulated industry ... Compiles and writes training material and conducts training sessions on QMS & Quality assurance activities. * Manage and lead implementation of continuous… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …a science-related discipline. + Minimum of 8+ years of directly related Quality Assurance experience in the medical device industry. + Knowledge of and ... **Job Duties** + Supports supplier quality activities for sourced finished Medical Device products and leads these supplier audits in accordance with… more
- Lilly (Concord, NC)
- …to make life better for people around the world. **Responsibilities:** The Quality Assurance Process team member is responsible for demonstrating leadership, ... teamwork, and quality knowledge on a day to day basis. They...process team for one of following manufacturing areas: + Device Assembly + Packaging + Project Focus for DAP… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... We are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are developed in accordance with Abbott's design control… more
- Medtronic (Juncos, PR)
- …2+ years of experience in equipment validation, process validation, or quality assurance in medical device , pharmaceutical, or biotech industries. + ... validation protocols to ensure equipment, systems, and processes meet regulatory, quality , and performance requirements under FDA, ISO 13485, and GxP frameworks.… more
- Insight Global (Danvers, MA)
- …preferred). Experience: -3+ years in sterility assurance or microbiological quality within medical device , pharmaceutical, or biotech industries. ... in sterility assurance , microbiology, and regulatory compliance within a medical device environment. Key Responsibilities -Develop, implement, and maintain… 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 FDA and CE Notified Body inspections + Experience in product quality assurance , process quality , verification and validation + Experience with… more
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