- Gilead Sciences, Inc. (Foster City, CA)
- …improvement. + Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards. + Maintain compliance with global Risk ... Management processes in accordance with ISO 14971 and other applicable standards. + Collaborate with SMEs from R&D, Clinical, and Operations to ensure comprehensive… more
- AeroVironment (Simi Valley, CA)
- …Black Belt or Master Black Belt; Project Management Professional (PMP); Certified Lead Auditor for AS9100/ ISO 9001. + Excellent written and verbal communication ... that all embedded Quality teams operate in compliance with ISO 9001, AS9100, or other relevant standards. + Lead...experience in a leadership role. + Expertise in AS9100, ISO 9001, ITAR, CMMI, and defense quality standards. +… more
- Saildrone (Alameda, CA)
- …for relevant teams across the company * Managing the audit process, from auditor selection to interviews to report response * Continuous monitoring of internal ... security models, especially Amazon Web Services * Previous successful audits for ISO 27001, PCI-DSS, or similarly complex standards * Excellent written and spoken… more
- ITT (Santa Rosa, CA)
- …ensure quality goals and objectives of the company are in accordance with ISO 9001. + Participate in the establishment and implementation of quality specifications, ... Operations and engineering experience are preferred. + Preferred certifications: ATEX auditor , ISO9001 lead auditor , Certified Quality Engineer + Experience… more
- DoorDash (San Francisco, CA)
- …Exposure to functional safety and risk-based engineering for mobile or safety-critical platforms ( ISO 26262, ISO 13849, or similar). + Demonstrated ability to ... 29, 2024. The Covey tool has been reviewed by an independent auditor . Results of the audit may be viewed here: Covey (https://getcovey.com/nyc-local-law-144)… more
- Highmark Health (Sacramento, CA)
- …Health Information Trust Alliance (HITRUST), and International Organization for Standardization ( ISO ) 27001. + Prepare and present solution decks to different levels ... Knowledge of HITRUST CSF, NIST 800-83 cyber security framework, PCI, HIPAA, HITECH, COBIT, ISO 27001/2, and ITIL 3 + Knowledge of NIST Risk Assessment methodology +… more
- DoorDash (San Francisco, CA)
- …+ Leverage your understanding of leading industry regulations and standards, including NIST, ISO 27001, SOC 2, and PCI DSS and provide recommendations to the ... of IT and cybersecurity frameworks and standards (eg, NIST, ISO 27001, SOC 2, PCI DSS). + You have...The Covey tool has been reviewed by an independent auditor . Results of the audit may be viewed here:… more
- Three Saints Bay (San Diego, CA)
- …with emphasis on managing quality management systems. + Qualified as a Lead Auditor for ANSI-Z540.1, ANSIZ540.3, or ISO 17025. **Compensation: $100K - $150K** ... **Position is located in San Diego, CA.** VEVRAA Federal Contractor Three Saints Bay, LLC and its subsidiaries offer a team-oriented working environment and the opportunity to work with exceptional, dedicated industry professionals. We offer our employees a… more
- J&J Family of Companies (Santa Clara, CA)
- …device industry is strongly preferred + Strong understanding of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems + Strong technical writing skills + Effective ... capability analysis, DOE, MSA, Gage R&R), Six Sigma, Lean + Certifications (CQE, Lead Auditor , Six Sigma, Project Management) would be a plus + Able to lift objects… more
- J&J Family of Companies (Santa Clara, CA)
- …principles and practices of related specialties. Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is ... requires conformance. + May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset. Familiarity with IEC 60601 and IEC… more