- Imperative Care (Campbell, CA)
- …Care's business objectives. + Lead the design assurance team and ensure compliance with domestic and international regulatory standards (eg, FDA, CE marking, etc.). ... Body, FDA, etc.) and internal audits to maintain regulatory compliance . + Oversee quality and compliance issues,...+ Expert knowledge of FDA regulations, EU regulations, and ISO standards. + Superior ability to manage complex projects… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …& Abilities:** + Familiarity with risk management activities that support BD's compliance with various international regulatory bodies, including ISO 14971 and ... Staff Engineer - Risk Management is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle… more
- AeroVironment (Simi Valley, CA)
- …organization in high-level cross-functional meetings and executive updates. + Ensure compliance with applicable standards including AS9100, ISO 9001, ITAR, ... and Supply Chain to ensure suppliers meet AV's quality, delivery, and compliance expectations. This role plays a pivotal part in advancing continuous improvement,… more
- Abbott (Sylmar, CA)
- …software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485. + Knowledge of quality management techniques and the application and principles ... non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in… more
- IQVIA (Valencia, CA)
- …will also be overseeing EHS programs across multiple sites, ensuring compliance with IQVIA Laboratories Corporate/Global EHS programs and applicable regulations. ... unit level for one or multiple sites to ensure compliance with IQVIA Laboratories Corporate EHS policies and regulatory...regulations, environmental laws, and safety standards. + Knowledge of ISO 14001 and ISO 45001. We put… more
- Element Materials Technology (Concord, CA)
- …customer expectations at Element Concord. The Manager's main duties are to ensure compliance and accuracy when reporting results to clients. The Manager must provide ... management system, client requirements, and regulatory requirements as applicable ie ISO /IEC 17025:2017, USP, GMP, FDA, and ICH guidelines. The **Quality Manager**… more
- Danaher Corporation (Sunnyvale, CA)
- …manufacturing and product lifecycle quality by implementing a risk-based approach to ensure compliance with corporate policies, 21 CFR 820, ISO 13485, and other ... providing strategic input on design control, risk management, and quality compliance . + Drive risk assessment activities including safety, design and process… more
- NOV (Bakersfield, CA)
- …to the Director of Quality. + Oversee document control activities to maintain compliance . + Conduct internal audits of the Quality Management System. + Participate ... in Material Review Board (MRB) activities. + Ensure compliance with UL 1316 standards and internal FGS procedures....check. + Strong mathematical aptitude required. + Experience in ISO , API, ASME, or similar certified environments preferred. +… more
- Ralliant (San Jose, CA)
- …Perform calibrations in accordance with company procedures and applicable standards ( ISO /IEC 17025, ISO9001, AS9100, ANZ540.1). - Specialize in overall calibration ... - Accurately document calibration results, ensuring traceability, completeness, and compliance . - Maintain and verify calibration standards and escalate equipment… more
- Abbott (Sylmar, CA)
- …+ Define and execute the global QA strategy for Digital Solutions + Ensure compliance with all applicable standards and regulations (eg, FDA 21 CFR Part 820, ... ISO 13485, ISO 14971, IEC 62304, EU...ISO 13485, ISO 14971, IEC 62304, EU MDR) + Prepare for...Abbott businesses and functions to educate and embed quality compliance throughout the product lifecycle + Build and lead… more