- Medtronic (Los Angeles, CA)
- …phases of the product development lifecycle, from feasibility and design to validation , launch, and post-market support. + Develop and maintain comprehensive project ... + Ensure compliance with internal and external regulatory requirements (eg, FDA , ISO) throughout the project. + Drive continuous process improvement initiatives… more
- Medtronic (Northridge, CA)
- …of ISO 10993 and global medical device regulations (eg, EU MDR, FDA , REACH, Prop 65). + Experience with biocompatibility assessments, toxicological risk evaluation, ... testing. + Knowledge of design control, risk management, and design verification/ validation processes. + Strong technical writing, data analysis, and statistical… more
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Associate Director, Quality Assurance (Computer System Validation) - Hybrid
- Merck & Co. (Rahway, NJ)