- Abbott (Alameda, CA)
- …documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate. + Leads ... + Some working knowledge of applicable regulations such as FDA , QSR, ISO, MDD, or IVDD + Some knowledge...knowledge in the areas of design controls, verification and validation activities, manufacturing practices and statistical techniques. + Some… more
- Stryker (San Jose, CA)
- …capital acquisition activity including equipment selection, procurement, installation and validation . + Analyze equipment to establish operating data, conduct ... Interactions. + Experience working with external suppliers for process verification/ validation . + Ability to interpret, analyze, and test electrical designs… more
- J&J Family of Companies (Santa Clara, CA)
- …label files used for printing product labels. + Create and execute process validation protocols and reports. + Other duties as assigned. These job requirements are ... compliance with applicable Quality System requirements such as QSRs, FDA , ISO, MDD, MDR and other applicable regulations. +...of Lean and Six Sigma concepts. + Experience with Validation of Medical Devices (IQ-OQ-PQ). + Basic understanding of… more
- Fortive Corporation (Irvine, CA)
- …excellence** through automation and Lean methodologies. **Regulatory Compliance & Validation ** + Ensure **Building Management Systems (BMS) and Environmental ... (EMS)** maintain GMP compliance. + Lead **IQ, OQ, PQ validation ** for facility, automation, and process systems. + Ensure...facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP, OSHA, and safety regulations** . +… more
- Abbott (Temecula, CA)
- …to ensure Design for Manufacturability. + Draft, review or execute verification / validation protocols, identify validation risks and impacts. + Works on complex ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Cytel (Sacramento, CA)
- …support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . + Collaborate with ... + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want our employees to succeed and… more
- Element Materials Technology (Concord, CA)
- …requirements, and regulatory requirements as applicable ie ISO/IEC 17025:2017, USP, GMP, FDA , and ICH guidelines. The **Quality Manager** monitors and advises on how ... ISO 17025 accreditation. + Leads and provides oversight to the Validation and Calibration Services (VCS) department, ensuring applicable regulatory standards are… more
- Teleflex (Pleasanton, CA)
- …accuracy of content and compliance with Design Control Procedures. * Support process validation for processes and products including IQ, OQ, PQ & PPQ. * Develop ... existing test methods * Provide R&D support for verification, qualification, and validation studies on existing products. * Support risk management activities and… more
- Imperative Care (Campbell, CA)
- …the company's bench testing technologies & competencies. Including test method validation and training. + Collaborate with cross-functional partners to identify ... new solutions, and incorporate continuous improvements stemming from technology advancement, FDA feedback, and/or applicable standards What You'll Bring + Bachelor's… more
- Abbott (Temecula, CA)
- …activities to achieve program objectives. + Transfer of molds to new suppliers; validation of injection mold tooling and process at new suppliers. + Regularly ... molding/two shot molding and resin changes. + Write specifications; design verification/ validation protocols and report. + Capacity analysis and long-range planning… more