Qualifications:

BS degree in Electrical Engineering, preferred, others accepted

Must have 5+ years of quality engineering experience, preferably with capital equipment including process validation, experience in FDA regulated industry

Must have strong knowledge of production and process controls in a regulated industry

Must have experience in a medical device manufacturing, with working knowledge of risk management. (21CFR820, ISO 13485, MDD requirements

Must have experience with test methods and standards for the validation of manufacturing of medical devices

Must be skilled in test plan development and root cause failure analysis and working knowledge of supplier quality management.

Strong verbal and written communication skills especially technical report writing.