- Actalent (Irvine, CA)
- …including the development and maintenance of risk management files, ensuring compliance with ISO 14971. + Develop and implement quality plans. + Ensure post market ... and procedures related to medical device manufacturing + Working knowledge of EN ISO 13485, ISO 14971, IEC 62304 and FDA QSR for Medical Devices + Ability to… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …and risk across the platform. + Lead Risk Management activities in compliance with ISO 14971 for products under design authority. + Serve as a member of the ... knowledge of: + 21 CFR Part 820 + MDD 93/42/EEC + MDR 2017/745 + ISO 13485 + ISO 14971 + Expertise in: + Design Controls + Change Control + Risk Management +… more
- Parker Hannifin Corporation (Richmond, CA)
- …the Division's products and services through the implementation of ISO 9001, problem-solving tools, prevention methods, quality-at-the-source and continual ... of Quality, Engineering or related experience. + Thorough knowledge of International Standard ISO 9001 Quality Management Systems ( ISO /TS 16949 as applicable for… more
- Wacker Chemical (San Diego, CA)
- …or related field) + 5-8 years of experience in a FDA and GMP regulated industry. + ISO 7 & ISO 8 gowning experience is preferred. + Familiarity with a variety of ... Office Suite. + Knowledge of regulatory requirements, including FDA, GMP, and ISO standards. + Requires good written, verbal, and interpersonal communication skills… more
- Abbott (Pomona, CA)
- …rooms and equipment. **WHAT YOU'LL DO** + Applies basic understanding of FDA, ISO and cGMP theories and principles. + Contribute to Group's objectives by carrying ... development, implementation and effectiveness of Abbott Quality Management System per ISO , FDA, and other regulatory agencies. + Responsible for exhibiting… more
- Actalent (Vista, CA)
- …and maintenance of the Quality Management System, obtaining FDA and ISO certifications, and product submission and registration. Responsibilities + Plan and ... Perform other duties as assigned or as business needs require. Essential Skills + ISO auditing + Quality Management System (QMS) + Quality assurance + Medical device… more
- Cognizant (Sacramento, CA)
- …IBM i environments. + Familiarity with security frameworks and standards such as ISO 27001 (ISMS), ISO 31000 (Risk Management), HITRUST CSF, NIST Cybersecurity ... FedRAMP, and ARC-AMPE. + Professional certifications such as CISSP, CISA, or ISO 27001 Lead Implementer/Lead Auditor are preferred. + Experience integrating IBM i… more
- Wacker Chemical (San Diego, CA)
- …expert (SME) for metrology. + Ensures compliance with regulatory standards (eg, GMP, ISO 17025). Plays a key role in strategic planning for metrology programs and ... by ASQ) + 8-10+ years of experience in a FDA and GMP regulated industry. + ISO 7 & ISO 8 gowning experience is preferred. + Ability to travel up to 5%. + Basic… more
- Sacramento Municipal Utility District (Sacramento, CA)
- …metal fabrication, and assembly; applicable industry standards such as ANSI, IEEE, NEMA, ICEA, ASTM, ISO 9000, ISO 9001 and ISO 9002; federal, state, and ... local laws, codes, and regulations governing manufacturing and safety; SMUD policies, procedures, applicable MOUs, and other special agreements; principles, procedures, and practices related to basic civil engineering design requirements utilized in the design… more
- Parker Hannifin Corporation (Irvine, CA)
- …the division's products and services through the implementation of ISO 9001, problem-solving tools, prevention methods, quality-at-the-source and continual ... leading teams in complex environments. - Thorough knowledge of International Standard ISO 9001 Quality Management Systems ( ISO /TS 16949 as applicable for… more