- Praxair, Inc - a Linde Company (Fresno, CA)
- …assigned locations in training Managers, supervisors and personnel on Company and FDA GMP procedures + Audit/Assess assigned LG&E manufacturing and warehousing ... personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure Quality incidents… more
- Fortive Corporation (Irvine, CA)
- …PQ validation** for facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP , OSHA, and safety regulations** . + Support **regulatory ... operations, engineering, automation systems, and process improvements** in a ** GMP -regulated manufacturing environment** . This role ensures **compliance, efficiency,… more
- Wacker Chemical (San Diego, CA)
- …or engineering (Chemical, Mechanical, or related field) + 5-8 years of experience in a FDA and GMP regulated industry. + ISO 7 & ISO 8 gowning experience ... well as Microsoft Office Suite. + Knowledge of regulatory requirements, including FDA , GMP , and ISO standards. + Requires good written, verbal, and interpersonal… more
- Abbott (Temecula, CA)
- …engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA , GMP , and ISO 13485 + Solid communication and interpersonal ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- System One (Irvine, CA)
- …years of manufacturing experience with 10+ years in a management role + FDA GMP regulation experience + Requires breadth of organizational, professional field ... device manufacturer, is seeking a hands-on change agent to lead operations at a GMP -regulated site-to step into a Site General Manager role. If you thrive in a… more
- ThermoFisher Scientific (Fremont, CA)
- …quality and regulatory standards **Knowledge, Skills, Abilities** + Knowledge of manufacturing techniques, FDA , GMP , and ISO 13485 compliance + Proven ability to ... Shift (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Laboratory Setting, Office, Some degree of PPE… more
- ThermoFisher Scientific (Fremont, CA)
- …regulatory compliance for medical devices or diagnostics. + Strong technical skills in FDA , GMP , ISO 13485 compliance, process improvement, and development. + ... lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some… more
- Abbott (Pleasanton, CA)
- …+ Engineering experience and demonstrated use of Quality tools/methodologies + Detailed knowledge of FDA , GMP , ISO 13485, and ISO 14971 + Solid communication and ... Control Plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, processes,… more
- Envista Holdings Corporation (Pomona, CA)
- …evaluate the current process and process changes. + Maintains a working knowledge of FDA GMP , ISO 13485 standards and other applicable standards. + Documents ... statistical software (Minitab, JMP, etc.) + Certified Quality Engineer preferred. + FDA Quality System Regulation Part 820 and ISO 13485 experience highly desired… more
- Kelly Services (Petaluma, CA)
- …medical devices, pharmaceuticals, or combination products. + Strong working knowledge of FDA regulations, GMP , and 510(k) pathways. + Excellent documentation and ... + Partner with engineering and quality teams to ensure FDA compliance on validations, CAPAs, and process changes. +...validations, CAPAs, and process changes. + Prepare and support FDA submissions, including Class I device registrations, Class II… more