- Abbott (Alameda, CA)
- …to assess compliance to the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project...Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the… more
- DEKA Research & Development (Manchester, NH)
- …with regulatory requirements and support QMS compliance. + Ensure ongoing compliance with FDA 21 CFR Part 820 and ISO 13485, maintaining the integrity and ... and compliance with regulatory requirements. + Support external audits (eg, FDA , ISO, customer audits) by preparing documentation, facilitating audit logistics, and… more
- Good Sense Foods (New Hope, MN)
- …leads the sanitation team, monitors work, ensures compliance with regulatory guidelines ( FDA , USDA, SQF, etc.), and works closely with production and quality ... Understand and ensure compliance with all Good Manufacturing Practices (GMPs), HACCP, FDA , USDA, and BRC standards. * Maintain accurate sanitation records, including… more
- US Foods (Lexington, NC)
- …maintenance. * Support the FSQA Manager to Ensure regulatory compliance with USDA, FDA , State and local authorities and act as division's primary liaison with these ... safety and raw material compliance specifications * Manage labeling compliance with USDA/ FDA regulations * Ensure complete data collection and trending on relevant… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicating in a professional and timely manner. + Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary ... FDA point of contact for projects of responsibility. +...of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more
- Mentor Technical Group (Caguas, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... the product - assist in process validation protocol. * Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends. *… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface with the FDA ... MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR's (21 CFR Part 820) **Required Knowledge and Skills** +… more
- Abbott (Alameda, CA)
- …reporting, including but not limited to: + Complaints trending and summaries + FDA Medical Device Reporting (MDR) trending and summaries + EU Medical Device ... (EMS), and other regulatory requirements. + Ensure compliance with FDA regulations, international regulatory requirements, and corporate/divisional policies, procedures,… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Support company goals and objectives, policies, and procedures, QSR, and FDA regulations. + Other duties as assigned. **Requirements** + Bachelor's degree and ... Quality System Certification is a plus + Experience with FDA /ISO Audits, NCR, and CAPA experience is a plus...and verbal communication skills + Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality… more
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