Position Overview Start-up medical device company seeking a highly skilled and experienced Operations Engineer II. The successful candidate will play a key role in overseeing and optimizing manufacturing processes' for medical devices. […]
Ensure all manufacturing activities are conducted in compliance with the company's Quality Management System (QMS) and applicable policies, including accurate documentation and comprehensive reporting. […]
Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485 Experience with risk management methodologies...