- Intuit (San Diego, CA)
- …industry best practices and regulations. Keep abreast of changes to the standards like ISO 27001, NIST and other relevant regulations. Lead and mentor a team of ... information technology best practices and control frameworks such as ISO 27001, NIST CSF and ISO 42001...such as ISO 27001, NIST CSF and ISO 42001 + AWS practitioner/associate, CISA or CISSP certifications… more
- NVIDIA (Santa Clara, CA)
- …and qualification plans: coupon and assembly-level testing (ASTM/ ISO /G-series), electrochemical methods (EIS, potentiodynamic), elastomer swell/durometer retention, ... pressure/thermal cycling, HALT/HASS, cleanliness verification ( ISO 4406/MIL-STD-1246C), life modeling & acceleration factors. + Run failure analyses and close the… more
- J&J Family of Companies (Santa Clara, CA)
- …US Food and Drug Administration (FDA) regulations, other regulatory requirements ( ISO ), Company policies, operating procedures, processes, and task assignments. + ... task outcome. + Experience working in regulated product and manufacturing environments ( ISO , FDA, cGMP). + Knowledge of and compliance with applicable Quality System… more
- US Tech Solutions (Mountain View, CA)
- …with engineering and product teams to validate compliance with audit controls (eg, ISO 27001, SOX). + Monitor and ensure completion of critical activities such as ... audit track + Audit or Compliance Experience (Strongly Preferred) + Knowledge of ISO 27001, SOX, and related audit frameworks. + Familiarity with controls, audit… more
- US Tech Solutions (San Bruno, CA)
- …**Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from the medical device ... and risk management files. **Risk Management and Usability Engineering:** 1. Integrate ISO 14971 risk management and IEC 62366 usability engineering activities with… more
- Imperative Care (Campbell, CA)
- …SCARs, etc.). + Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards ( ISO 14971) and ... good manufacturing practices. + Excellent communications skills (both written and verbal). + Proven ability to provide thorough and meticulous review of documents. + Proven ability to write clear, concise, and well thought out technical documentation with… more
- Abbott (Pomona, CA)
- …managing projects through the phase gate process while ensuring compliance with FDA, ISO 13485, and other international standards. The Project Manager will play a ... priorities concurrently. + Knowledgeable of federal and other regulations, eg QSR's, ISO , ISO 13485, CMDR. + Understands and is aware of the quality consequences… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …and design change control process in accordance with 21 CFR Part 820 & ISO 13485. + Support regulatory submissions as technical lead. + Own project deliverables from ... market. + Expertise with design controls (21 CFR Part 820, ISO 13485) & risk management ( ISO 14971). + Working experience in medical device regulations and… more
- Gilead Sciences, Inc. (La Verne, CA)
- …improvement initiatives + Knowledge of applicable standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366 + Preferred knowledge of Six ... (DMAIC) methodology, performance measures and quality improvement statistics + Knowledge of ISO 14971 Risk Management tools (eg, Hazard Analysis and Critical Control… more
- Turner & Townsend (San Francisco, CA)
- …Quality Control - Ensure compliance with quality standards and participation in ISO audits. + Develop priority plans including risk mitigation through internal ... facilities + Deep understanding of Good Manufacturing Practice (GMP), FDA, ISO , and other relevant standards. + Familiarity with cleanroom classifications, HVAC… more