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Sr. Quality Assurance Manager
Job Description
Senior Quality Assurance Manager
Clinton Township, MI
Direct Hire | Full-Time | On-Site
$150, 000–$170, 000 + Excellent Benefits
Are you an experienced Quality leader with a strong background in medical device manufacturing, ISO 13485, FDA compliance, and Quality Management Systems?
We're partnering with an innovative manufacturer seeking a Senior Quality Assurance Manager to lead Quality strategy, regulatory compliance, and continuous improvement initiatives across the organization. This is an excellent opportunity to make a significant impact while leading a talented quality team in a highly regulated manufacturing environment.
What You'll Do
- Lead and continuously improve the company's Quality Management System (QMS).
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, ITAR, and customer requirements.
- Oversee CAPA, nonconformances, customer complaints, audits, validations, and regulatory compliance.
- Serve as the primary Quality representative during customer, certification, and regulatory audits.
- Lead, mentor, and develop the Quality team while partnering with Engineering, Manufacturing, and Operations.
- Drive continuous improvement initiatives that enhance product quality, compliance, and operational performance.
What We're Looking For
8+ years of Quality experience in a regulated manufacturing environment
Leadership experience managing Quality teams
Strong experience with:
- ISO 13485
- FDA 21 CFR Part 820 / QMSR
- CAPA
- Internal & External Audits
- Validation (IQ/OQ/PQ)
- Quality Management Systems
Medical device manufacturing experience
Highly Preferred
- Plastic injection molding experience
- ITAR experience
- ASQ Certification (CQE/CQA) or Six Sigma
If you're interested—or know someone who would be a great fit—I'd love to connect!
Meet Your Recruiter
Chris Ingersoll
Technical Recruiter
With over two decades dedicated to talent recruitment and staffing management within dynamic agency settings, Chris possesses extensive experience across diverse industries. Throughout her career, her primary focus has always been on prioritizing the delivery of high-quality staffing solutions.
Chris consistently strives to match the right talent with the right opportunities, ensuring that both clients and candidates benefit from a seamless and mutually rewarding experience. This commitment to excellence has been the cornerstone of her approach in facilitating successful placements and fostering long-term professional relationships.
Chris's journey has sharpened her ability to handle intricate staffing needs while nurturing strong connections with clients and candidates. As always, she is committed to offering tailored solutions that contribute to organizational growth.