- Hologic (San Diego, CA)
- …Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other applicable quality and regulatory standards. + Extensive experience and understanding of ... Quality Engineer, Design Control San Diego, CA, United...related initiatives with NCE and CAPA process. + Support regulatory inspections and audits associated with design control documentation.… more
- ITT (El Cajon, CA)
- …analytics, structured problem-solving, and cross-functional collaboration to uphold rigorous quality standards, regulatory compliance, and customer satisfaction ... electronics, or high-precision manufacturing is required. + Hands-on experience with quality systems, inspection techniques, and regulatory compliance (AS9100,… more
- Terumo Neuro (Aliso Viejo, CA)
- …teams by ensuring incoming materials and finished products meet the established quality standards and world-wide regulatory requirements. Ability to handle the ... (CFR 21 820 and ISO 13485). 5. Ability to follow company, quality and regulatory procedures and standards. 6. Good written and verbal communication skills. 7.… more
- V2X (China Lake, CA)
- …audits or quality reviews of processes, procedures, operating conditions, compliance to quality and regulatory standards. + Must be able to travel 50% + ... of both NTWP locations (Pt. Mugu, VX-30 and China Lake, VX-31) Quality Management System. Manages through guidance, direction, and leadership to experienced… more
- University of Southern California (Los Angeles, CA)
- …the CDPH, CMS and the TJC. + Req Knowledge of requirements for external quality and safety organizations, regulatory agencies and accreditation standards. + Req ... statistical methods for data collection and analysis. Knowledge of healthcare quality principles and regulatory compliance principles. Preferred Qualifications:… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** Reporting to the SVP of Global Regulatory Affairs, Patient Safety and Quality , the VP of R&D Quality ... Quality and Medical Governance organization in meetings with regulatory authorities and other stakeholders around the world +...the world + Oversee the management of all R&D quality issues, including regulatory compliance with CAPAs,… more
- Medtronic (Los Angeles, CA)
- …integration** (eg, MES, ERP, LIMS, QMS, data lakes/platforms) + Understanding of ** quality systems** , regulatory requirements (FDA, ISO), and GxP environments ... the Life** Careers That Change Lives: In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …platform team leaders, operating with independence but under oversight from senior quality and regulatory compliance leaders. **Key Responsibilities** + This ... with us. **Position Summary** The Senior Manager of EMI (Electromechanical Instrumentation) Quality Sustaining Engineering reports to the Global Director of EMI … more
- Actalent (Irvine, CA)
- …the development, maintenance, and improvement of technical documentation, including SOPs, quality manuals, policies, procedures, and regulatory submissions. The ... documentation for vendors and manufacturing sites, such as batch records, quality reports, and regulatory filings. + Collaborate with R&D, quality , and… more
- Gilead Sciences, Inc. (La Verne, CA)
- … functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving a culture of quality and continuous ... Leadership & Strategy** + Develop and execute the site's quality strategy aligned with corporate objectives and regulatory... quality strategy aligned with corporate objectives and regulatory expectations. + Serve as the site's quality… more