- Integra LifeSciences (Plainsboro, NJ)
- …overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations ... patient outcomes and set new standards of care. The ** Quality Inspector I** will be responsible for performing ...clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. * QA experience in… more
- J&J Family of Companies (Raritan, NJ)
- …robust GxP Quality Management System of a diverse portfolio of drug and medical device health products and services. This individual serves as the clinical ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Clinical Quality **Job...field and/or equivalent time and experience in a related medical device R&D area + Good understanding… more
- Integra LifeSciences (Princeton, NJ)
- … mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring ... such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility...or related discipline, with 5+ years of experience in Quality Assurance role for medical device… more
- Integra LifeSciences (Princeton, NJ)
- … mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring ... of care. This position is for a Sr. Supplier Quality Engineer l - Global Supplier Quality ...such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility… more
- Sanofi Group (Morristown, NJ)
- …or equivalent with at least 8 years relevant experience in the pharmaceutical, biotech, medical device , or related industries. + At least three years relevant ... **Job Title:** Global Quality Auditor **Location:** Morristown, NJ, Framingham, MA, Swiftwater,...+ Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and Skills: **Qualifications** + Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Integra LifeSciences (Plainsboro, NJ)
- …US. Food and Drug Administration Regulations, ISO 9001, ISO 13485:2016 Standard, European Medical Device Directives, Canadian Medical Device Regulations, ... pathways to advance patient outcomes and set new standards of care. The ** Quality Compliance Specialist** will provide quality compliance support to the Collagen… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Integra LifeSciences (Princeton, NJ)
- …and demonstrate an understanding of FDA Regulations, ISO 13485 Standard, European Medical Device Regulation, Canadian Medical Device Regulations, ... provides support across multiple functional areas, including regulatory intelligence, device establishment registration and listing (FURLS), global unique device… more
- Kelly Services (Somerset, NJ)
- …systems or applications support within a regulated industry (pharmaceutical, biotech, or medical device ). + Experience with system validation and compliance ... ** Quality Validations Engineer- Somerset NJ** **Summary of Essential...(eg, MasterControl), LIMS, and ERP systems. + Familiarity with FDA 21 CFR Part 11 compliance and data integrity… more