- Hologic (San Diego, CA)
- …Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other applicable quality and regulatory standards. + ... risk control measures. + Support design control and risk management activities, review/approve design control and...ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing… more
- GE Vernova (CA)
- …safety, planning & tracking project design reviews, design optimization, On Time Delivery, risk management , and quality control/ quality assurance. + ... project manager. + The Sr. Engineer is responsible for technical change control and risk management . + Accountable with the PED for the performance of… more
- US Tech Solutions (San Bruno, CA)
- …Files (DHF) including development plans, verification and validation plans, requirements specifications, and risk management files. ** Risk Management and ... Usability Engineering:** 1. Integrate ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes. **Training and Compliance:**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …device combination product development projects, with a strong emphasis on design control and risk management activities. * Oversee design control, risk ... and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments. * Develop and/or review controlled… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …and meet customer expectations for safety and effectiveness. Reporting to the VP, Quality Management WW IPD & MDS Manufacturing EMEA, the Director provides ... The role also ensures the maintenance of a robust Quality Management System (QMS) aligned with corporate...between pumps and sets, including alignment and consistency in risk management files, coordinated change control processes… more
- Stryker (Irvine, CA)
- …manufacturing processes that support new product development projects. You will also lead risk management activities to ensure the highest level of product and ... systems by identifying and correcting procedural deficiencies. + Lead risk management activities and present final ...product drawings. + Evaluate predicate devices and define critical quality attributes through risk analysis. + Contribute… more
- Abbott (Alameda, CA)
- …and Key processes that govern the area by promptly addressing non-compliance issues. Risk Management + Ensures evaluation of product safety and efficacy and ... serve people in more than 160 countries. **Sr. Specialist Quality Assurance Engineer** **- Williamson** **Working at Abbott** At...of risk -based issues. + Creates and reviews risk management documentation to reduce or eliminate… more
- Abbott (Menlo Park, CA)
- … risk reduction, and cost containment. + Deep understanding of risk management in design, manufacturing and post-market surveillance. + Demonstrated ... Work On** + Provide leadership in direct support of medical device manufacturing. + Management and development of Quality Engineers and Technicians. + Own the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …combination product development projects, with a strong emphasis on design control and risk management activities. + Collaborate with device engineering on new ... and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments. + Develop and/or review controlled… more
- Southern California Edison (Chino, CA)
- Join the Clean Energy Revolution Become a Safety Quality Senior Advisor on the Safety Management System (SMS) team at Southern California Edison (SCE) and build ... tomorrow. In this job, you'll be responsible for developing quality assurance and quality control checks for...with recommended sampling and inspection standards, and will facilitate risk discussions with leaders and project teams to identify… more