- 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
- 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...and tools (eg, Hazard Analysis, FMEA). + Knowledge of ISO 14971 Risk Management processes. + ASQ certifications (Certified… more
- Oracle (Sacramento, CA)
- …regulatory, and product leadership teams to align development activities with ISO 14971, IEC 62366, and EU/US Clinical Evaluation standards. Key Responsibilities ... . Conduct and contribute to clinical risk analyses (per ISO 14971). . Collaborate on Failure Mode and Effects...within healthcare technology or medical devices. . Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance… 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
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …of regulatory requirements and quality standards in the medical device industry (FDA, ISO 13485, ISO 60601) + Excellent problem-solving skills and ability to ... Vascular, or Cardiac Surgery + Good understanding of design controls (IEC 62366, ISO 14971, 21 CFR 820) + Experience with Device Connectivity and Cloud-based… more
- AeroVironment (Simi Valley, CA)
- …Improvement** + Ensure that all embedded Quality teams operate in compliance with ISO 9001, AS9100, or other relevant standards. + Lead initiatives to close systemic ... experience in a leadership role. + Expertise in AS9100, ISO 9001, ITAR, CMMI, and defense quality standards. +...SPC, GD&T, MSA, etc.). + Knowledge of BMS frameworks ( ISO 9001, AS9100, or industry equivalent). + Proficiency with… 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 ... and ensure alignment with compliance frameworks including FedRAMP, SOC 2, and ISO 27001. Responsibilities + Lead end-to-end execution of complex DevOps and… more
- Teledyne (Goleta, CA)
- …knowledge of Geometric Dimensioning and Tolerancing (GD&T) and datum structures. + Understanding of ISO standards, including ISO 9001 and ISO 14001. + ... Experience with metrology and inspection methods, including contact and optical CMMs, handheld tools, and electronic test instruments. + Knowledge of audit processes and requirements. + Awareness of Electrostatic Discharge (ESD) controls and best practices. +… more
- Teleflex (Pleasanton, CA)
- …* Expertise in SolidWorks. * Exceptional verbal and written communication skills. * Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and ... FDA QSR. * Experience developing mechatronic products with IEC 60601 is a plus. * Medical device experience is required. * Experience in robotics, motor control systems, embedded systems, or hardware/software integration is a plus. **Specialized Skills / Other… more
- WSP USA (Los Angeles, CA)
- …information security controls in accordance with NIST Cybersecurity Framework and ISO 27001 standards **Service Desk Leadership** + Lead, manage, and improve ... with information security policies and implement security controls per NIST and ISO standards + Conduct security assessments and maintain documentation for audit… more