Design Control Quality Engineer

Education
• B.A. or B.S. degree in a technical discipline, such as engineering or science
• Certified Quality engineer is a plus.
Knowledge/Experience
• Experience with active medical devices, containing hardware, software and sterile surgical invasive components.
• 5+ years of relevant experience in the medical device industry.
• Design Controls experience and strong knowledge of risk management including generation of system risk documentation.
• Working knowledge of ISO 13485, 14971, 21 CFR 820, and MDD/MDR.
• Working knowledge of medical device international standards.
• Working knowledge of problem solving and statistical methods as applied to process and product quality preferred. Experienced with statistical tools (e.g., Minitab) is a plus.
• Knowledge and understanding of the Human Factors Usability Engineering process is a plus.
• Knowledge and understanding of Design V&V Validations, Process, Test Method and Equipment Validations (IQ, OQ, PQ).
• Ability to work independently with minimal work direction and in a cross-functional team environment.
• Ability to effectively communicate written and verbally
• Ability to manage time effectively to ensure timely completion of tasks
• Sound knowledge of quality management systems.
• Strong PC Skills. Computer proficiency: Microsoft Word, Excel, and Office.
• Detail oriented.