We’re a mid-sized medical device and contract manufacturer looking for a Quality Manager to lead our Quality Management System (QMS) in a regulated manufacturing environment. The successful candidate will have a strong background in quality management, experience in CAPA execution, complaint resolution, and audit preparation, and a proven track record of driving continuous improvement and safeguarding product quality and customer satisfaction.
Requirements
- Bachelor’s degree in Engineering, Quality, Life Sciences, or related field (or equivalent experience)
- 5+ years of progressive quality experience in a regulated manufacturing environment (medical devices strongly preferred)
- Strong working knowledge of FDA 21 CFR Part 820 and/or ISO 13485 requirements
- Direct experience leading CAPA, complaint handling, nonconformance, and audit processes
- Demonstrated ability to apply root cause analysis and risk-based thinking to complex quality issues
- Proven experience working cross-functionally with engineering, operations, and leadership teams
- Experience participating in or leading internal and external regulatory audits
- Ability to analyze quality trends and drive systemic improvements
- Strong communication skills with the ability to influence across functions
Benefits
- Health, dental, vision, basic life, and AD&D insurance
- 401(k) retirement plan with employer match
- Paid time off (Vacation and Protected paid time) and 6 company designated holidays
- Tuition Assistance Program
- Employee Brace Program
