QA Manager II

Full-Time | On-Site - Tennessee

Our client is a well-established FDA-regulated manufacturer that develops and produces products serving healthcare and consumer markets. As part of a growing quality organization, they are seeking an experienced Quality Assurance Manager II to lead Quality Assurance, Quality Control, and Quality Engineering functions at a state-of-the-art manufacturing site.

This role is a key member of the site leadership team and will partner closely with Operations, Engineering, Product Development, and Corporate Quality to drive continuous improvement, maintain regulatory compliance, and support operational excellence.

• Lead Quality Assurance, Quality Control, and Quality Engineering activities across the site.
• Oversee investigations, deviations, nonconforming materials, CAPAs, and quality system processes.
• Drive continuous improvement initiatives focused on product quality, compliance, and operational performance.
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality management systems.
• Lead internal audits, customer audits, and regulatory inspections.
• Collaborate with suppliers, customers, and cross-functional stakeholders on quality-related initiatives.
• Support new product introductions, process validation programs, and risk management activities.
• Develop, mentor, and lead a high-performing quality organization.
• Participate in site quality reviews, management reviews, and strategic planning activities.
  
  

• Bachelor's degree in a scientific, engineering, or technical discipline.
• 10 years of Quality leadership experience within an FDA-regulated manufacturing environment.
• Experience leading Quality Assurance, Quality Control, and/or Quality Engineering teams.
• Strong knowledge of:
  • FDA regulations (21 CFR Parts 11, 210, 211, and/or 820)
  • ISO 13485
  • cGMP manufacturing environments
  • Quality Management Systems (QMS)
  • CAPA, Root Cause Analysis, and Risk Management
  • Process, Cleaning, Software, and Analytical Method Validation
  • Statistical Process Control (SPC) and Lean Manufacturing methodologies
    
    

• Experience within pharmaceutical, medical device, healthcare, consumer products, or other highly regulated manufacturing environments.
• Professional quality or regulatory certifications are a plus.
  
  

This is an opportunity to step into a highly visible leadership position with a growing manufacturer committed to quality, operational excellence, and continuous improvement. The successful candidate will have the ability to influence site strategy, develop talent, and play a critical role in ensuring product quality and regulatory compliance.