- Astrix Technology (Irvine, CA)
- …System policies and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies pertaining ... (eg MDRs, Vigilance reports, etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and… more
- ManpowerGroup (Newark, OH)
- …facility. This is a key plant-level leadership role responsible for food safety, product quality , and regulatory compliance - with direct oversight of the QA ... QA professionals. **Key Responsibilities:** + Lead food safety and quality initiatives, ensuring compliance with regulatory , GFSI...standards + Serve as point of contact for USDA, FDA , and other agency inspections + Conduct audits on… more
- J&J Family of Companies (Gurabo, PR)
- …for the roles including but not limited to: critical thinking and leadership, quality systems and regulatory expertise, risk management and audit readiness, ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Control **Job Category:** People… more
- Catalent Pharma Solutions (Kansas City, MO)
- …+ Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations. + Monitor site compliance to FDA , EU and all ... Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit ensuring expectations are met consistently and at a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …PDM functions including Product and Portfolio Strategy, Global Manufacturing,Supply Chain, Regulatory CMC, and the wider Quality organization to achieve ... testingprograms, policies,and procedures to ensure compliance withGxPstandards, corporate policies, FDA , EMA,and other regulatory body regulations and… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …Engineering is responsible for the management, direction and coordination of all quality and regulatory compliance activities across the designated Columbus ... and Sterilization control to ensure that the required production, quality and regulatory standards are achieved through...at the designated BU Columbus plant. + Interfaces with Regulatory Agencies ( FDA , ISO notified body, other… more
- Takeda Pharmaceuticals (Boston, MA)
- …auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high- quality standards, this role supports ... my knowledge. **Job Description** **About the role:** The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of… more
- Dentsply Sirona (Lancaster, PA)
- … excellence across distribution operations, ensuring alignment with regulatory requirements, corporate standards, and customer expectations. **Key ... + Maintain systems, processes, and documentation to support compliance with FDA , ISO 13485, and other applicable international quality standards.… more
- Merck (Rahway, NJ)
- …process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ... teams to improve processes related to device-drug integration. + Partner with Quality and Regulatory teams to ensure compliance with applicable global… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …development and change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions (eg, 510(k), Q-Sub), EU ... compliance. + Serve as a point of contact for FDA , EU Notified Bodies, and other regulatory ...in a scientific, health sciences, or technical discipline (eg, Regulatory Affairs, Quality Assurance, Engineering, Bioengineering, Biology,… more
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