About this role
Senior Quality Engineer - Metals at Penumbra, Inc.. Location: Alameda, California, United States. Role: supporting manufacturing, leading investigations, improving inspection Requirements: Bachelor's in engineering, 5+ years quality/manufacturing engineering in medical devices, knowledge of FDA QSR and ISO 13485, strong data analysis and problem-solving, experience with pFMEA, NCR/MRB/CAPA processes. Category: Engineering Seniority: Senior Level Tools: 5 Why, Fishbone Diagram, Design of Experiments (DOE), regression analysis, pFMEA, Measurement System Analysis (MSA), FDA QSR, ISO 13485, NCR, MRB, CAPA Certifications: cqe, six sigma black belt Commitment: Full Time Workplace: Onsite Languages: English