- pony.ai (Fremont, CA)
- …eg Camera, Lidar and Radar etc. + Familiar with industry safety standards and regulations eg ISO 7637, ISO 16750, ISO 26262 etc. + Experience with developing ... and collaborating with oversea suppliers Compensation and Benefits Base Salary Range: $120,000 - $220,000 Annually Compensation may vary outside of this range depending on many factors, including the candidate's qualifications, skills, competencies,… more
- Abbott (Alameda, CA)
- …+ The incumbent also has a significant interaction with FDA / ISO during inspections. **Required Qualifications** + Bachelor's or Master's degree in Engineering, ... organizations. + Substantial knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971. + Minimum 5 years Complaint Handling Experience. **Preferred… more
- Abbott (Alameda, CA)
- …inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP. The Compliance Specialist will lead and support ... + Monitor and ensure compliance with applicable regulatory standards applicable to ADC ( ISO 13485, MDSAP, 21 CFR Part 820, etc.). + Maintain audit schedules,… more
- Abbott (Alameda, CA)
- …assess compliance to the requirements of the quality system, as well as FDA, ISO , MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. This ... medical device industry + Min 8 years auditing per ISO and/or FDA standards. + Knowledge of MDD, CMDR,...or other geographic regulations. + Lead Auditor Certification for ISO 13485 or 9001:2000. + Proficient writing skills required.… more
- Abbott (Alameda, CA)
- …maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as ... Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304. In particular, has… more
- Gilead Sciences, Inc. (Foster City, CA)
- …relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead's quality system requirements. * Plan and ... intervals), test method validation (MSA, Gage R&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these… more
- Deloitte (San Diego, CA)
- …working with Cloud security industry standards such as Cloud Security Alliance (CSA), ISO /IEC 27017 and NIST CSF + 2+ years working experience with Cloud security ... requirements related to information security and cloud computing such as ISO 27001, ISO 27018, NIST CSF, NIST 800-53, PCI DSS, SOC2, HIPAA, PCI,… more
- quadric.io, Inc (Burlingame, CA)
- …in functional safety development. + Knowledge of Quality Management Systems like ISO 9001 or equivalent + Knowledge of a Functional Safety standard, preferably ... ISO 26262 + Experience working with 3rd party auditors...working with 3rd party auditors and participation in successful ISO certifications Benefits + Provide competitive salaries and meaningful… more
- Imagine One Technology & Management (San Diego, CA)
- …programs; profit sharing; advancement opportunities; and much more!** **_ISO 9001:2015, ISO 20000-1:2018, ISO 27001:2013_** **_CMMI Development and Services - ... Maturity Level 3_** **_An Employee-Owned Business_** **_EEO/Veterans/Disabled_** _Imagine One "Contingent" offers for employment may stipulate that one or more requirements be satisfied before final commitment between candidate and Imagine One is established;… more
- Rheinmetall (Fresno, CA)
- …Homologar y cualificar proveedores segun nuestros procedimientos internos y la normativa ISO 9001:2015. + Realizar auditorias tecnicas para asegurarse de que los ... clave: + Calidad en entorno industrial, especialmente aplicada a proveedores. + Normativa ISO 9001 y herramientas de mejora continua (PDCA, 8D, etc.). + Procesos de… more