- Actalent (Irvine, CA)
- …manufacturing and field environments. + Apply quality engineering tools such as process validation , equipment qualification, test method validation , sampling ... compliance with regulatory standards and internal requirements. This role focuses on process , equipment, and design verification and validation , while providing… more
- Jabil (San Jose, CA)
- …contamination control initiatives, including cleanroom design, environmental monitoring, and process validation . + Responsible for leading technical cleanliness ... guidance on contamination control, cleanroom design and operation, and cleanliness validation for components, assemblies, and processes. This role will be based… more
- J&J Family of Companies (Irvine, CA)
- …an FDA and European regulatory environment + Expertise in NPD (New Product Development) process and Design/ Process Validation + American Society for Quality ... of risk management activities + Support development and execution of relevant process development and validation activities (eg IQ/OQ/TMV/APQ) + Utilizes… more
- J&J Family of Companies (Irvine, CA)
- …FEA, DOE's, simulated use testing, etc.), and support development of product and process validation plans and testing. The candidate will also be involved ... Management Engineer will provide technical support to external manufacturers in process development, characterization, validation and stabilization. + The Staff… more
- Terumo Neuro (Aliso Viejo, CA)
- …other engineering tasks. Evaluate, initiate, and establish improved engineering and process validation . Work closely with Manufacturing, Quality, Regulatory, and ... to oversee multiple process improvements to ensure readiness for process validation and alignment with company goals. + Evaluate, create, and initiate… more
- Micron Technology, Inc. (San Jose, CA)
- …within Micron and with our CPU partners. + Continuously refine the platform validation process with enablers and Micron partners to deliver TTM leadership ... leadership features and outstanding products. + Own and drive the enabler Platform validation function and forums, such as weekly core team meetings, bi-weekly sync,… more
- Actalent (San Clemente, CA)
- …and cardiovascular device development. + Proficiency in regulatory compliance, design control, process validation , and root cause analysis. Additional Skills & ... and efficient operations. Responsibilities + Guide and oversee product and process validations, including sterilization validation and revalidation. + Lead… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation , cleanroom classification and qualification, new product ... + Accountable for multiple external QA functions, including quality events, validation , and release/disposition. + Partner with internal stakeholders such as Global… more
- Mitsubishi Chemical Group (Irvine, CA)
- …Federal, Fire Department, Air Quality Management District (AQMD) etc. are maintained. Perform validation process to ensure results are achieved to the baseline. ... ** Process Engineer (2105)** + Title: Process Engineer + Group Company: Mitsubishi Chemical Carbon Fiber & Composites + Location:Irvine, CA Group Company: +… more
- Caldera Medical (Westlake Village, CA)
- …* Lead purchase part approval processes. Contribute to risk analysis (PFMEA), validation plans, control plans, evaluate process capability (Cpk, Ppk), and ... Knowledge of Design Control procedures and requirements. * Experience with test method validation and product/ process changes/ validation . * Ability to work… more