Quality Manager (Medical Device)

Quality ManagerMedical device manufacturer in the greater Knoxville, TN area has an immediate opening for a Quality Manager. This is a smaller company that develops and manufactures complex equipment for use in hospital settings. This Quality Manager will be responsible for handling 3rd party audits and ensuring 21 CFR Part 820 regulations are met. The company has a strong Quality program in place with zero findings from the FDA on their last audit. The company wants to continually improve the Quality program to ensure all details are addressed. Qualified candidates will have a BS degree along with at least 5 years Quality experience working with Medical Device manufacturers. Ideally looking for a Quality Manager who has strong experience leading 3rd party audits. Currently, there will not be anyone reporting directly to the Quality Manager, but that could eventually change. The main focus is finding a Quality Manager with strong skills leading audits and ensuring compliance with 21 CFR Part 820 and ISO 13485. Excellent company culture with good work / life balance. Relocation assistance is available.