- Keeper Security, Inc. (El Dorado Hills, CA)
- …FedRAMP and StateRAMP Authorized, SOC 2 compliant, FIPS 140-2 validated, as well as ISO 27001, 27017 and 27018 certified. Keeper deploys in minutes, not months, and ... or tabletop simulations + Experience supporting regulated environments (SOC 2, FedRAMP, ISO 27001, etc.) Benefits + Medical, Dental & Vision (inclusive of domestic… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired ... **Desired Qualifications:** + Graduate degree in Mechanical Engineering, Biomedical Engineering or related field + 4+ years of post-educational experience in Medical Device Design highly desired + Design for Six Sigma, Design for Manufacturability training /… more
- MetaOption, LLC (Sunnyvale, CA)
- …incidents. * Ensure logging, auditing, and reporting meet FDA, HITRUST, ISO 27001 and healthcare industry standards-including data retention, traceability, and ... systems subject to FDA GxP and HITRUST compliance; familiarity with HIPAA, SOC2, ISO 27001 frameworks. * Strong skills in scripting/automation (Python, Bash, Go). *… more
- Philips (San Diego, CA)
- …years' experience leading and managing people. New product development experience preferred. Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR + Strong ... understanding of design quality tools, methods and activities + Strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analyses + Demonstrated expertise in managing complex projects and implementing… more
- Keysight Technologies, Inc. (Roseville, CA)
- …to SI units. Maintain working knowledge of current quality standards including ANSI/ ISO 9001, ANSI/Z540.3, and ISO /IEC 17025. + Perform calibration, adjustment, ... diagnosis, and troubleshooting of test and measurement equipment down to the assembly level. + Take independent action and initiative, interfacing effectively with team members, customers, and management. + Adhere to the highest standards of business ethics. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Stay current with industry standards and regulatory expectations** , including FDA, EMA, ISO 13485, ISO 14971, and cGMP. **Basic Qualifications:** + Doctorate ... OR + Master's and 4+ years of relevant experience OR + Bachelor's and 6+ years of relevant experience OR **Preferred Qualifications** **:** + Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related… more
- Prime Matter Labs (Torrance, CA)
- …Develop and maintain supplier quality assurance programs aligned with FDA, ISO 22716 (GMP for cosmetics), and other applicable regulations. Conduct supplier ... ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ISO 13485 Lead Auditor Certification. Demonstrated leadership and management skills,… more
- Trescal (San Jose, CA)
- …not limited to: Physical, Dimensional & Electronics + Working knowledge of ISO /IEC 17025 and ANSI/NCSL Z540-1 requirements + Strong communication skills including ... overnight) And we would prefer: + Knowledge of ANSI / NCSL Z-540-1,17025 and ISO 9000 BENEFITS: We believe people are the most important part of every business,… more
- Danaher Corporation (San Diego, CA)
- …guides, and instructions that strictly adhere to FDA, EU MDR/IVDR, and ISO 13485 requirements, ensuring all materials are audit-ready. + Collaborate with Subject ... and quality standards, including FDA (21 CFR Part 820), EU IVDR/MDR, and ISO 13485. + Demonstrated expertise with a Content Management System (CMS) or authoring… more
- Vestis Services (Los Angeles, CA)
- …**Compliance & Safety** + Ensure equipment and processes meet ISO cleanroom standards, GMP requirements, and customer-driven specifications. + Maintain ... water systems, and low-voltage control systems. + Knowledge of ISO classifications, contamination control, and cleanroom protocols. + Boiler operator… more