- Medtronic (Northridge, CA)
- …and business impact. + Ensure compliance with all regulatory, audit, and FDA requirements in manufacturing and quality. + Drive accountability and transparency ... leading multi-disciplinary IT teams across multiple sites. + Experience in FDA -regulated or similarly controlled environments strongly preferred. + Proven ability to… more
- Rady Children's Hospital San Diego (San Diego, CA)
- …compliance with regulatory and accrediting agency requirements including but not limited to AABB, FDA , CADPH, JCAHO, CAP and OSHA. Serves as a role model and mentor ... and nonconformances and reports non-conformances meeting requirements directly to the FDA (BPD reporting). MINIMUM QUALIFICATIONS: Bachelor's Degree 5 Years of… more
- Danaher Corporation (Sunnyvale, CA)
- …assessment to identify and implement improvements. This position reports to the Senior Manager Quality Systems - Compliance and is part of the Quality Systems ... with effective corrective actions + Support external audit management (eg, FDA , ISO, corporate, foreign governments, etc.,) including pre-audit, during audit, and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …maintenance, and OOT records to comply with ISO 13485, ISO 9001, and FDA regulations. + Provide input to the Calibration and Equipment Maintenance Manager ... equivalent certification is preferred. + Knowledge of ISO 13485, ISO 9001, and FDA regulations is highly At BD, we prioritize on-site collaboration because we… more
- Stanford University (Stanford, CA)
- …world of health care in the cancer arena. Reporting to the GI Oncology Research Manager , the CRC2 will be conversant in the goals, mission and priorities of the ... investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. +… more
- Danaher Corporation (Sunnyvale, CA)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance. This position is part of the Quality department ... . + Participate in external audit management ( eg FDA , ISO, Danaher Corporate, foreign governments), in either a...and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation… more
- Astrix Technology (San Bernardino, CA)
- …+ Assist in the investigation of customer complaints. + Support the QC Manager /Supervisor with special projects. + Ensure compliance with all company policies and ... food industry. + In-depth knowledge of food safety programs and compliance ( FDA , USDA, HACCP, GMP, Allergen Programs). + Understanding of labeling regulations… more
- Vera Therapeutics (Brisbane, CA)
- …will oversee clinical and commercial supply chains, ensuring alignment with FDA /EMA standards, cold chain logistics protocols, and enterprise-wide risk management ... cost sheets, etc. Compliance & Regulatory Oversight * Ensure full compliance with FDA , EMA, GMP, GCP, GDP, and SOX regulations across all supply chain activities,… more
- Sysco (Fremont, CA)
- …any manner capable of during emergencies the plant President or GM (general manager ) determines are paramount to the business. + Frequently interacts with the ... **Education** + Formal job training in TQM principles, SPC, HACCP concepts, CFIA/ FDA regulations would be beneficial. + Formal quality and sensory analysis training… more
- Abbott (Alameda, CA)
- …Quality System Requirements. + Works independently with objectives given by SWQA Manager . + Can plan and coordinate own work according to higher-level project ... of departmental operating procedures to ensure compliance to relevant FDA , QSR, ISO guidelines, including 21 CFR Part 11...Quality Assurance and/or Software Testing experience. + Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part… more