- Medtronic (Los Angeles, CA)
- …exhausted. This activity may include travel to sites to perform both system repair, validation , and data gathering + Validation of warranty claim submissions and ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Kelly Services (Sacramento, CA)
- …with cGMP regulations, internal quality standards, and applicable regulatory requirements (eg, FDA , EMA, MHRA). The QA Manager will lead a team in managing ... quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with… more
- AbbVie (Pleasanton, CA)
- …Cpk Lead or support design activities including design verification, validation , specification setting & justification, test method development, usability ... + Plan & conduct product & process verification & validation , including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification… more
- J&J Family of Companies (Santa Clara, CA)
- …quality and manufacturing requirements, process/technology development, product verification/ validation , manufacturing, supplier controls, post market surveillance, ... teams and business functions, manage audit/inspection outcomes with Notified Bodies and FDA , lead and drive effective oversight of CAPA Program and drive… more
- ABM Industries (Carlsbad, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Understands and is aware of the ... in their area of responsibility, including product design, verification and validation , manufacturing and testing activities. + Serve as system administrator,… more
- The Clorox Company (Pleasanton, CA)
- …excellence during manufacturing. You will have experience in reporting for EPA or FDA regulated OTC products. You will work closely with Scientists and our business ... action regarding assay/product optimization, and/or troubleshooting as needed. + Validation and transfer of analytical methodologies to R&D, Contract Research… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and quality. + Provide expert-level understanding of qualification and validation , nonconformance control, process capability, risk reduction, and supplier ... a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface with the FDA … more
- Abbott (Alameda, CA)
- …the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and ... **What you'll work on** + Lead software development, verification, and validation for embedded biowearable products, ensuring on-time delivery within budget. +… more
- Hologic (San Diego, CA)
- …in supporting quality activities related to Design Control efforts in accordance with FDA , ISO, and other IVD regulations. You will also support the company's ... quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. **Key Outcomes** + Work… more
- Abbott (Alameda, CA)
- …**What you'll work on** + Lead software development, verification, and validation ; responsible for on-time delivery of high-quality embedded software biowearable ... approved design control procedures for software development in accordance with FDA guidelines. + Lead software development projects, providing mentoring and… more