- UGI Corporation (Rocklin, CA)
- …Operations Rep (ISOR) is to ensure an excellent AmeriGas onboarding experience. The ISO 's main objective is to complete accurate processing of customer data in a ... through account administration activities. Duties and Responsibilities: + The ISO ensures timely and accurate customer account administration, processes and… more
- Link Solutions Inc (Monterey, CA)
- …and compliance-focused, under our guiding philosophy, "Mission First, Customer Always". We are ISO 9001:2015, ISO 20000-1:2018, ISO 27001:2022 certified and ... appraised for CMMI ML3 for Services and Development. Link Solutions is seeking a Network Engineer (Senior-Level) to join our team in Monterey, CA. + Must be a US Citizen + DoD Secret Clearance required (Active or Interim) + Must possess Extreme Networks… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …organizational skills. + Detail-oriented and comfortable working in a fast-paced environment. + Knowledge of ISO 14971, ISO 13485, ISO 9001, 21 CFR Part 820 ... At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per… 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
- Mitsubishi Chemical Group (Sacramento, CA)
- …1.1 Implementation and management of the Quality Management System. (QMS, AS 9100/ ISO 9001). This shall include: 1.1.1 Implement, manage and maintain the AS ... 9100/ ISO 9001 QMS & certifications. Locations: Sacramento Plant, Sacramento...Manage the internal audit program for Quality (AS 9100/ ISO 9001). Responsible for managing external Quality audits with… more
- ThermoFisher Scientific (Fremont, CA)
- …and production and laboratory standards are in compliance with all GMP, ISO , FDA, OSHA and other company manufacturing and safety guidelines. Ensures quality ... systems are effectively maintained to achieve strong levels of GMP/ ISO /FDA/OSHA compliance . Responsible for meeting financial targets, key measurements and… more
- Oracle (Sacramento, CA)
- …documentation, Traceability Matrices, and Verification Plans. + Update and maintain ** ISO 14971-compliant risk management files** , hazard analyses, and FMEAs. + ... Experience with one or more of: + MDR (Medical Device Regulation) + ISO 14971 (risk management) + ISO 13485 + IEC 62304 + SaMD (Software as a Medical Device)… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR. + Lead risk management activities ( ISO 14971), including ... Strong knowledge of design control, risk management, and regulatory standards (FDA, ISO , IVDR). + Experience in companion diagnostics, flow cytometry or clinical… more
- Abbott (Sylmar, CA)
- …quality managed industries. + Working knowledge of applicable regulations, such as FDA QSR, ISO , MDD, &/or IVDD. + Detailed knowledge of FDA, GMP, ISO 13485, ... and ISO 14971 Solid communication and interpersonal skills. Preferred Experience: + Masters Degree Preferred + ASQ CQE or other certifications preferred. Please note that the salary range listed is our full grade range. We usually hire based on the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and Gilead's quality system requirements. Plan and ... intervals), test method validation (MSA, GageR&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these… more