Quality Manager (FDA regulated)

Quality Manager (FDA regulated)

• Knoxville, TN
• Direct Hire
• Job ID: TN08-2735035

Medical Device manufacturer in eastern TN has immediate need for a Quality Manager with strong experience in FDA-regulated manufacturing environment. This company is growing and adding new equipment, so the Quality Manager will be involved in Validations for new equipment and processes. Will train Quality team members on Inspections, Document Control, GMP compliance, etc. The Quality Manager will ensure compliance with FDA regulations in addition to managing the Quality Lab. Knowledge of CAPAs and root cause analysis is important. Will ensure KPI targets are met. The Quality Manager is also heavily involved in customer interaction. This is a well-established corporation with multiple sites in the U.S. Excellent opportunity to join a company launching several new products that will expand their market share. Qualified candidates will have BS degree along with at least 3 years Quality management experience. ASQ certifications are a plus. Must have prior experience with FDA audits, regulatory agency interaction, and ISO certification processes. Relocation Assistance is available.