Director, Design Quality Assurance - Pleasanton, CA

The Director, Design Quality Assurance provides strategic representation, planning, management, direction, and guidance to meet quality engineering goals and objectives supporting new product development and sustaining commercial products.

Requirements

• Bachelor of Science in Engineering or Life Science discipline
• Minimum 15 years experience in Quality Engineering/Assurance in the medical device industry including 5 years in a managerial role
• Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO 13485 and 14971, 62366; IEC 60601-1, IEC 62304 and related regulations

Benefits

• 401(k)
• Healthcare insurance
• Paid vacation