- Amentum (Sacramento, CA)
- **Amentum seeks an ISO 27001 Compliance Engineer** Amentum is a global leader in advanced engineering and innovative technology solutions, trusted by the United ... than 53,000 employees in approximately 80 countries across all 7 continents. The ** ISO 27001 Compliance Engineer** is a remote-telework position that supports our … more
- Fujifilm (Hollister, CA)
- …plan meeting safety, quality, business, and customer needs. Participate in and support ISO 9001, ISO 14001 and ISO 45001 certifications. Coordinate ... cause analysis tools. Employ safety regulations, including Process Safety Management and ISO standards ( ISO 9001, ISO 14001, ISO 45001). Manage plant… more
- AbbVie (Irvine, CA)
- …To be successful in this role you should have: + Knowledge of the ISO /CE process and global product registration process. Experience with eCTD tools and EDMS ... (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR....RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO /IEC 62366,… more
- Legrand NA (Moreno Valley, CA)
- …site compliance with OSHA, state and federal EPA regulations, and applicable ISO standards. Helps drive Legrand CSR, Corporate Social Responsibility, targets related ... with site leadership. + Implement and oversee the site's ISO 14001 environmental management processes and ISO ...site's ISO 14001 environmental management processes and ISO 45001 occupational safety and health management systems, ensuring… more
- Hologic (San Diego, CA)
- …of relevant quality system regulations (eg, 21 CFR Parts 806 and 820, ISO 13485, and ISO 14971). **Required Qualifications and Experience:** + Bachelor's, ... Experience with complaint investigation, CAPA, and quality systems (FDA, ISO 13485, EU MDR). + Understanding of 21 CFR,... 13485, EU MDR). + Understanding of 21 CFR, ISO 13485, ISO 14971 and other regulations… more
- NTT America, Inc. (Santa Clara, CA)
- …to conduct internal audits in line with the Integrated Management System (IMS), covering ISO standards eg ISO 14001, 27001, 45001, 50001 as well as supporting ... professional training/qualifications and experience in Internal Control System, internal auditing, ISO standards eg ISO 14001, 27001, 45001, 50001 or… more
- NVIDIA (Santa Clara, CA)
- …graphics, and multimedia processing. The system is certified for both automotive safety ( ISO 26262 ASIL-D) and cybersecurity ( ISO 21434, UN Reg 155), and ... Development Lifecycle and V-model + Practical knowledge of industry standards including ASPICE, ISO 25010, ISO 26262, ISO 21434 Ways to stand out from the… more
- J&J Family of Companies (Santa Clara, CA)
- …functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, ... of related specialties. Familiarity with FDA guidance documents and ISO and + ASTM standards related to quality and...auditor in ISO13485 would be an asset. Familiarity with ISO 14971, IEC 60601 and IEC 62304 is an… more
- Merck (Sacramento, CA)
- …in medical devices or combination products Experience in design controls, ISO 13485, deviation management, change control, risk management/ ISO 14971-2019 ... Deviation Management, Driving Continuous Improvement, Ethical Compliance, GMP Documentation, ISO 13485 Medical Devices, ISO 14971 Risk Management,… more
- Danaher Corporation (Sunnyvale, CA)
- …effective corrective actions + Support external audit management (eg, FDA, ISO , corporate, foreign governments, etc.,) including pre-audit, during audit, and ... standards including compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR)...including, but not limited to, 21 CFR Part 820, ISO 13485, MDSAP country related requirements (TGA, ANVISA RDC… more