- Fujifilm (College Station, TX)
- …integral member of the Global Supplier Quality Management team, the Supplier Quality Auditor Lead will be responsible for managing and leading the Supplier ... in support of supplier integrity and oversight. The Supplier Quality Auditor Lead is responsible forsupporting all...+ Experience working in an auditing role within the Pharmaceutical/ Medical Device industry. + Bachelor's Degree in… more
- Envista Holdings Corporation (Quakertown, PA)
- …regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster ... and professional relationships across the organization. **POSITION SUMMARY** The ** Quality Assurance Manager** ( QA Manager)...and Quality Systems in a regulated industry ( medical device or pharmaceutical area). + Exceptional… more
- West Pharmaceutical Services (Jersey Shore, PA)
- Manager Quality Assurance Requisition ID: 67310 Date: Nov 29, 2024 Location: Jersey Shore, Pennsylvania, US Department: Quality Description: At West, we're a ... on audit program priorities. + Generate, review, or approve Quality Assurance related documentation required for product....depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements. + Experience with SAP… more
- Pentax Medical (Montvale, NJ)
- … provides endoscopic imaging devices and solutions to the global medical community. The Medical Device Quality Engineer is an integral part of the QA ... and production of Quality Products. Position Opening: Medical Device Quality Engineer Why...Certified Quality Engineer (CQE) certification and/or Certified Quality Auditor (CQA). ISO 13485 lead … more
- West Pharmaceutical Services (Kinston, NC)
- …automations, and transfer from a quality point of view. + Support quality assurance improvement activities by evaluating products, processes or materials in ... QA Automation/Transfer Eng Requisition ID: 67164 Date: Dec...(Sr Assoc) of experience in a regulated industry (eg, Medical Device ), including Product Development, Product Manufacturing,… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Sr. Manager, Medical Device Quality Systems, is responsible for supporting ... both current and emerging regulations and standards impacting AbbVie medical device and combination products. + Performs...GXP regulated environment, with a minimum 3 years in Quality Assurance Operations Management. A strong technical… more
- Mallinckrodt Pharmaceuticals (Madison, WI)
- …external and supplier audits Preferences : + 3+ years working in medical device industry + Strong Statistical background + Auditor Certification (ASQ CQA or ... parts in SAP and on-site quarantine areas. + Develop, implement, and maintain Quality Assurance procedures, standards, and controls. + Support investigations of… more
- Pfizer (Collegeville, PA)
- …Combination and Medical Device Products. The incumbent provides quality assurance guidance of Packaging and Labelling for Pharmaceutical, Combination ... in quality investigation techniques and leads complex quality investigations and develops QA decisions. Actively...years' experience of working in a Quality Assurance , GMP manufacturing or Medical Device… more
- Integra LifeSciences (Cincinnati, OH)
- …education and years of management experience in QA /Compliance within Medical Device Industry. OR Master degree in Quality Assurance or related ... Assurance **Supervision Exercised** Audit Team Document Control/ Quality Records Personnel QA Analyst **Essential Duties...or equivalent education and years of management experience in QA /Compliance within Medical Device Industry.… more
- Sandia National Laboratories (Carlsbad, NM)
- …on to: + Serve as the Sandia QA lead for the SNL WIPP quality assurance program. + Assess current quality processes from various requirements including ... to lead Sandia's Waste Isolation Pilot Plant (SNL WIPP) Quality Assurance program. You will be expected...law. NNSA Requirements for MedPEDs: If you have a Medical Portable Electronic Device (MedPED), such as… more
- AbbVie (North Chicago, IL)
- …industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device , biologics and combination products, cosmetics, eye care or ... years of total relevant experience, including 4+ years in Quality Assurance with some project management experience... with some project management experience in the pharmaceutical, medical device , biotechnology or related industry and… more
- Abbott (Plymouth, MN)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...of education or work experience. + Minimum 3 years Quality Assurance , Internal Auditing, Quality … more
- Terumo Medical Corporation (Elkton, MD)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA… more
- Integra LifeSciences (Cincinnati, OH)
- …ability required for this position. **Education & Experience** + Bachelor's degree in Quality Assurance or Engineering or related discipline. + At least five ... external) + Member of Internal Audit Team + Other Quality duties as assigned by Director of QA...(5) years of experience in the Medical Device Industry or related industry. +… more
- Hologic (San Diego, CA)
- …experience and knowledge of the FDA Quality System Regulation, ISO13485, and the Medical Device Regulation. + 5+ years' experience in IVD/ IVDR or medical ... Knowledge** + ISO 13485 leader auditor + Working knowledge of Medical Device Regulations, IVDR, CFR 820, ISO-13485,ISO-14971,(Required). + Risk management… more
- Abbott (Pomona, CA)
- …of products to meet or exceed internal and external requirements. + Act as quality assurance support for the design and development/on-market support of In-Vitro ... Diagnostics (IVD) medical device products, facilitating the application of...+ Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, or Certified Quality Auditor… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …with engineering or supplier change process. 9. Audit experience in quality assurance activities for medical device and drug products. 10. Experience ... ten (10) to twelve (12) years of total supplier quality experience in a medical device...Six Sigma Black Belt Certified 4. ISO13485 Certified Lead Auditor 5. Certified Quality Engineer 6. Advanced… more
- Belcan (New Port Richey, FL)
- …Quality Management System tools and continuous improvement methodologies. * Demonstrated supply quality experience within the medical device industry. If ... with 7 years of experience in manufacturing, engineering or quality assurance . * Minimum 5 years experience...ASQ Certified Quality Engineer or CQA Certified Quality Auditor * Demonstrated knowledge of … more
- West Pharmaceutical Services (Exton, PA)
- …role will initially operate within the regulatory confines of a GMP pharmaceutical and medical device testing laboratory and must ensure all projects meet the ... Sr Quality Engineer, Integrated Systems Requisition ID: 66823 Date:...6 years of experience in a regulated industry (eg, Medical Device ), including Product Development, Product Manufacturing,… more
- J&J Family of Companies (Raritan, NJ)
- …+ Experience in information systems and/or GxP auditing within Pharmaceutical/ Medical Device company or direct experience with GxP Quality Assurance , ... implementation and/or validation of computerized systems within Pharmaceutical/ Medical Device company. + Knowledge of Quality System regulations, ISO,… more