Permanent position: Growing and national manufacturer is seeking a direct-hire Quality Manager. This position is located near Jefferson City, Tennessee. The Quality Manager will manage all quality systems, FDA requirements, and ISO regulations for a brand new product line as well as oversee a team of 10+ employees. The salary is commensurate with experience ranging from $90K to $110K, plus an opportunity for a bonus, and relocation if needed. All candidates must be legally authorized to work in the United States.Responsibilities for the Quality Manager
Requirements for the Quality Manager
- Maintain an effective quality system in accordance with Medical Device and Pharmaceutical rules and regulations
- Ensure products meet FDA requirements, ISO standards, and supplier quality agreements
- Determine root cause analysis as well as CAPA and verification of quality implementations
- Lead quality, continuous improvement, and quality investigation tools i.e. 5 Whys, Process Mapping, FMEA, Control Plans, etc.
- BS Degree is required
- Must have at least 3+ years of quality leadership experience in a medical device or pharmaceutical manufacturing background
- Strong experience with FDA inspections, regulatory agency interaction, and ISO rules and processes
- Strong background in CAPA Analysis, Corrective Action, Continuous Process Improvement, and Statistical Process Control
- Experience with Lateral Flow, ELISA, and/or Western Blot is a BIG plus!
- Full-Time permanent position
- Salary is dependent on experience ranging from $90K to $110K, plus an opportunity for a bonus and relocation assistance
- Full-time benefits, medical, dental, vision, PTO, etc.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.