- Grifols Shared Services North America, Inc (Van Nuys, CA)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Abbott (Milpitas, CA)
- …the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and ... biowearable products, ensuring on-time delivery within budget. + Implement FDA -compliant design control procedures. + Provide technical leadership and mentoring… more
- 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
- 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
- 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
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …+ Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Equivalency: In lieu of an Associate's degree, ... minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment. + Requires an in depth understanding of pharmaceutical manufacturing… more
- Astrix Technology (Fullerton, CA)
- …oversee daily QA operations, ensure regulatory and food safety compliance (eg, FDA , FSMA, GFSI), and support continuous improvement initiatives to uphold the highest ... Conduct internal audits and assist with external audits (eg, FDA , third-party, customer). + Train and mentor QA technicians...in a food manufacturing environment + Strong knowledge of FDA regulations, HACCP, GMP, and GFSI standards (SQF, BRC,… more
- Abbott (Alameda, CA)
- …the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and ... biowearable products, ensuring on-time delivery within budget. + Implement FDA -compliant design control procedures. + Provide technical leadership and mentoring… more
- Actalent (San Diego, CA)
- …Management System (QMS). This position ensures compliance with GMP requirements, FDA & ISO standards, and other applicable regulations. Key Responsibilities: + ... of: + Record retention practices + GMP & Good Documentation Practices + US FDA Quality System Regulations (QSR) + ISO 13485:2016 + Basic understanding of change… more
- Danaher Corporation (Sunnyvale, CA)
- …effective corrective action . + Participate in external audit management ( eg FDA , ISO, Danaher Corporate, foreign governments), in either a supporting or lead role, ... federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well… more