QA Manager II

About the role

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.

Responsibilities

• 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.

Requirements

• 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

Preferred Qualifications

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

Benefits

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.