Quality Engineer
Virtusoft - Los Gatos, CA

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SKILLS REQUIRED Only candidates with significant experience in the medical device industry will be considered BABS in Quality Engineering or related discipline Extensive experience with medical device QSRs in design control and production environment Class II or Class III medical devices product development experience Strong working knowledge of ISO 13485 14971 FDA QSR and MDD regulationsguidelines Strong verbal and written communication skills including technical report writing and presentations Demonstrated use of Quality toolsmethodologies including Design Control Risk Analysis (Hazard Analysis) Design FMEA Process FMEA Statistical Analysis and Gauge RR JOB RESPONSIBILITIES Work directly with operations management and production team to create compile institute quality metrics and corrective actions when necessary Provide validation support Lead complaint investigations and document findings providing necessary reports to clients and the CAPA system Establish and conduct a Failure Analysis Process to ensure product returns and internal product failures are investigated and documented in the CAPA system Evaluate and approve ECN changes for existing products and processes Participate in Material Review Board (MRB) and coordinate any necessary supplier corrective actions Review design for quality requirements prior to design transfer on all new production projects Please mail your profile at neelamsiwachvirtusoftus Quality Tools Medical device ISO FDA QSR MDD