- Fortive Corporation (Irvine, CA)
- …Ensure all designs and projects are compliant with GMP, FDA, ISO 13485, and applicable regulatory requirements. **Required Qualifications:** Bachelor's degree in ... (IQ/OQ/PQ). Familiarity with industry codes and standards (ASME, ASTM, ISO , FDA). Excellent analytical, problem-solving, and project management skills. Strong… more
- Abbott (Santa Clara, CA)
- …requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series. **Principal Responsibilities** + Manage direct staff conducting ... and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993 + Experience working with global regulations and requirements, especially… more
- Sony Pictures Entertainment (Culver City, CA)
- …Maintain a deep understanding of security regulations and frameworks (eg, NIST, ISO 27001, PCI DSS, OWASP, SAFECode) for designing systems and processes that ... + Proficiency in Major Frameworks: Demonstrated knowledge of NIST Cybersecurity Framework, ISO 27001/27002, PCI DSS (if handling payment card data), OWASP, SAFECode,… more
- General Motors (Mountain View, CA)
- …environments. + Ensure compliance with legal standards and safety requirements, including ISO 26262, SOTIF, FMVSS 111, and FMVSS 127, while improving test coverage ... and critical problem-solving skills. + Experience in Unified Diagnostic Services ( ISO 14229). + Knowledge of automotive communication protocols (Ethernet, DDS, CAN,… more
- SLAC National Accelerator Laboratory (Menlo Park, CA)
- …Certified Weld Inspector (CWI) credential. + Must have experience manufacturing assemblies in ISO 5 & 6 Cleanroom (Class 100 and 1000) environments. + Working ... knowledge of environmental and personnel protocols for performing work in ISO 5&6 Cleanrooms (Class 100 and 1000). + Ability to help define and deliver long- and… more
- Medtronic (Santa Ana, CA)
- …design input requirements in compliance with Design Controls Standards including ISO 5840. Leverage Mechanical Testing and Prototyping including mechanical testing ... and PDP; Designing implantable heart valves using SMA in compliance with ISO 5840; Mechanical Testing of heart valves, including tension, compression, bending,… more
- Belcan (Simi Valley, CA)
- …preferred * Experience and familiarity with quality industry standards such as AS9100, ISO 9001, and NQA-1 preferred. Skills and Knowledge: * Strong knowledge of ... y familiaridad con est*ndares de la industria de la calidad como AS9100, ISO 9001 y NQA-1. Habilidades y conocimientos: * S*lido conocimiento de los procesos… more
- BD (Becton, Dickinson and Company) (Temecula, CA)
- …methods, background information, and troubleshooting strategies, including cGMPs and relevant ISO and ASTM guidelines. + Adheres to ZebraSci Quality Systems, ... (specifically mentioned as "desirable") + Knowledge of GLP, cGMPs, 21 CFR820.30, ISO and ASTM procedures (listed as "beneficial") + Proficiency in CAD (SolidWorks)… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Expert knowledge of 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, ISO 13485, ISO 14971, and other international standards, as required + Expert knowledge of ... design controls and risk management + Experience in front room and support room during internal and external audits + Experience in navigating complex regulatory and product certification landscapes + Knowledge and experience in making field action and… more
- Abbott (Sylmar, CA)
- …and demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. + Solid communication and interpersonal skills. ... + Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner + Advanced computer skills, including statistical/data analysis… more