- Element Materials Technology (Santa Fe Springs, CA)
- …Acting as a key link between the laboratory teams and the Quality Manager , this role ensures that all testing activities are executed with accuracy, efficiency, ... standards. The role requires a deep understanding of GMP, ISO 17025, FDA, and ICH requirements, as well as...the primary liaison between laboratory staff and the Quality Manager to ensure alignment on priorities and deliverables +… 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 ... (FDA, EU MDR, etc.). * ASQ certification (Engineer or Manager ) preferred. * Six Sigma Green Belt or Black...Part 820 + MDD 93/42/EEC + MDR 2017/745 + ISO 13485 + ISO 14971 + Expertise… more
- Adecco US, Inc. (Carlsbad, CA)
- …Engineer I, II, III** **Job Summary** **Reports To:** Engineering Manager **Status:** Exempt **Employment Type:** Full-time **Position Overview** The Manufacturing ... and maintain documents, procedures, work instructions, and forms for ISO compliance + Develop monthly quality summary reports +...(J-STD) + Knowledge of quality system standards: + AS9100, ISO 9001, ISO 13485 + Familiarity with… more
- Silvus Technologies (Los Angeles, CA)
- …is seeking a **Supplier Quality Compliance Officer** who will report to the Quality Manager on the Quality Control team. This individual will oversee and ensure the ... compliance of Silvus' supply base with applicable quality standards, including ISO 9001:2015 and AS9100. This role will focus on supplier audits, supplier… more
- Medtronic (Northridge, CA)
- …collaboration with multidisciplinary and cross-functional teams to ensure compliance with ISO 10993 standards and global medical device regulations. The role also ... biological assessments of material and device safety in accordance with ISO 10993-1 by conducting chemical characterization analysis impact assessments for changes… more
- RTX Corporation (Fullerton, CA)
- …activities for business development. + You will act as the Cost Account Manager (CAM) for Estimate at Completion (EAC) reviews. **Qualification You Must Have** **:** ... of relevant experience in the areas below; + Working experience with ISO 9001 and/or AS9100 Quality Management Systems. + Working experience translating external… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …us. **Position Summary:** + Reporting to a more senior level engineering staff/ manager or higher, this associate will bring engineering skills. The associate will ... process in accordance with 21 CFR Part 820 & ISO 13485. + Support regulatory submissions as technical lead....+ Expertise with design controls (21 CFR Part 820, ISO 13485) & risk management ( ISO 14971).… more
- Abbott (Alameda, CA)
- …Quality System Requirements. + Works independently with objectives given by SWQA Manager . + Can plan and coordinate own work according to higher-level project ... operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott...+ Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part… more
- Amphenol CIT (Cerritos, CA)
- …(VST) and technicians. They work under the guidance of the quality manager . They are responsible for planning, initiating, coordinating, and evaluating activities ... and 2+ years' experience in a leadership role in Quality within an ISO and AS9100-controlled or government-regulated environment. + Experience in Root Cause Analysis… more
- Envista Holdings Corporation (Pomona, CA)
- …Sr. Quality Engineer will report directly to the Quality Engineering Manager . **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Actively participates in defining customer ... process and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards. + Documents data obtained during all… more