Overview As the MQA Manager at the Cedar Creek site, you will lead quality assurance to ensure compliant manufacturing and release of products. You will manage a QA team, drive continuous improvement, and support audits with cross-functional partners. You'll oversee quality systems, deviations, CAPA, and change controls to uphold regulatory standards. This role sits on the site Quality Leadership Team and acts as a delegate to the Site Quality Head, shaping the site's quality culture and performance.
Compensation / Benefits- bonus eligibility
- stock options
- benefits
- competitive salary
Responsibilities- Lead, coach, and develop the Manufacturing Quality Assurance team; set priorities and monitor performance
- Ensure compliance with FDA, ISO, cGMP and company quality requirements; support audits and maintain inspection readiness
- Oversee quality system processes including deviations, investigations, nonconformances, CAPA, change controls, and rework
- Provide quality oversight for manufacturing operations, product release, and distribution according to procedures and regulatory requirements
- Manage batch record review, product disposition, material management, and release activities
- Oversee qualification/validation of equipment, processes, systems, and methods; drive root cause investigations and corrective actions
- Analyze quality data and trends to identify opportunities for improvement; lead Lean/Six Sigma initiatives
- Track, report, and communicate quality performance metrics; participate in Quality Management Reviews and site leadership meetings
Key requirements- 8+ years of quality experience in a regulated manufacturing environment
- 3+ years of people leadership experience
- Experience with Quality Management Systems (QMS) and regulatory interactions
- Strong knowledge of FDA regulations, ISO 13485, and cGMP
- Experience with audits/inspections and data-driven quality improvement
- Medical device or diagnostics manufacturing experience preferred
- Ability to travel occasionally
- leadership and coaching
- problem-solving
- risk assessment
- Quality Management Systems (QMS)
- FDA regulations and ISO 13485
- cGMP
