- Abbott (Sylmar, CA)
- …applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. + Identify and manage activities related to adding value to ... of software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485. + Knowledge of quality management techniques and the application and principles… more
- Astrix Technology (Los Angeles, CA)
- …and validation. + Participate in internal quality audits and contribute to ISO -compliant quality systems. + Review and approve receiving inspection requirements and ... analysis, FMEA, lean six sigma, audits, corrective actions. + GMP and ISO 13485 quality systems experience; medical instrumentation preferred. + Familiarity with… more
- NVIDIA (Santa Clara, CA)
- …FMEA, FTA) for complex software and hardware platforms. + Familiarity with safety standards ( ISO 26262, IEC 61508, ISO /PAS 21448) + Experience in the redaction ... of safety requirements and/or other safety collateral such as safety manuals and safety reports in an agile environment Ways to stand out from the crowd: + Hands-on experience with systems engineering methodologies such as model-based approaches, peer review… more
- Abbott (Sylmar, CA)
- …+ Ensure compliance with all applicable standards and regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, EU MDR) + Prepare for and lead ... audits **Strategic Leadership** + Act as the primary authority on quality matters related to digital technologies, including AI/ML, cloud platforms, and data interoperability + Provide strategic input into product development, risk management, and lifecycle… more
- Gentex Corp. (Rancho Cucamonga, CA)
- …with Gentex Corporation management expectations and systems certifications (AS-9100 and ISO 9001:2008) and develops metrics to measure continuous improvements to the ... assurance processes o Inspection techniques, physical testing, and measurement principles o ISO 9001, and AS9100 standards and regulations o GD&T principles and… more
- Banc of California (Santa Ana, CA)
- …also assist with the initial and ongoing due diligence of the Banc's PF/ ISO portfolio. Performs all duties in accordance with the company's policies and procedures, ... - + Oversee the (sub)merchant applications of PFs/ISOs to ensure strict adherence to PF/ ISO policies and procedures and the Banc's risk appetite. + Conduct Know Your… more
- 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 ... cybersecurity and enterprise IT environments with regulatory compliance (SOC 2, ISO 27001, FedRAMP, IL5) + Experience leading transformation programs, technology… more
- Hologic (San Diego, CA)
- …documentation, including development and notebook studies for operations. + Participates in FDA, ISO lab audits and performs BSL3 audits. + May represent group as ... + Strong mathematics skills. + Knowledge of ERP. + Knowledge of GMP/GLP, ISO and CDC Safety Regulations Blood Borne Pathogen Training **So why join Hologic?**… more
- Malin Space Science Systems (San Diego, CA)
- …maintains process controls (eg solder analysis). + Maintains externally accredited ISO 17025 equipment calibration program. + Maintains Foreign Object Elimination ... field or comparable technical experience. + 3+ years experience working with AS/ ISO family of standards especially AS9100. + Ability to work independently with… more
- Eaton Corporation (Camarillo, CA)
- …in aerospace products and applications. * Certified as Internal or Lead Auditor ( ISO 9001, AS9100, ISO 13485) preferred * Excellent communication and ... presentation skills - both verbal and written with ability to make necessary status reports and technical presentations to Eaton management and customer * Strong analytical skills and business acumen **Additional Information:** * Strong ethics, values and the… more