- Gilead Sciences, Inc. (Foster City, CA)
- …in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP BRH ... Release Process Optimization:** + Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to design SAP BRH… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... people in more than 160 countries. **Job Title** **Software Quality Engineer II** **Working at Abbott** At Abbott, you...systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …to support good understanding and knowledge of current regulatory requirements ie, FDA , ISO, and Takeda Quality Systems, and serve as a plant resource ... Assurance activities for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard… 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 ... in a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface with the … more
- Envista Holdings Corporation (Pomona, CA)
- …QUALIFICATIONS:** + Experience with statistical software (Minitab, JMP, etc.) + Certified Quality Engineer preferred. + FDA Quality System Regulation ... working closely with cross-functional teams to develop, implement, and maintain quality assurance protocols that comply with regulatory requirements and… more
- Danaher Corporation (Sunnyvale, CA)
- …(https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Quality Systems Specialist is responsible for functioning ... to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous and rigorous assessment to identify… more
- Cordis (Santa Clara, CA)
- …and collaborate with suppliers to improve product quality . + Support regulatory compliance by ensuring adherence to FDA and other relevant standards. ... of education and experience preferred + Expertise in the FDA and International Medical Device Quality System Regulations and ISO 13485 + Six Sigma, Lean… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …life sciences related field. + Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and ... understanding of design quality assurance. + Lead Quality System auditor experience. + Experience managing regulatory...21CFR, MDD 93/42/EEC, MDR 2017/745, ISO13485, and ISO14971 + Quality system auditing + Management of FDA … more
- 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
- Actalent (Irvine, CA)
- …seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and ... field (Master's preferred). + 8-10 years of experience in Quality Systems or Regulatory Affairs within the...within the medical device industry. + Strong understanding of FDA regulations and other relevant standards. + Experience with… more