Senior Quality Manager- Medical Device

The Senior Quality Manager will lead the full Quality function-including QA, QC, and Supplier Quality-while developing and executing the site's overall quality strategy to ensure regulatory compliance and consistently high product standards. This position blends strategic leadership with hands‑on oversight, driving a strong quality culture and aligning operations with customer, regulatory, and corporate expectations.

Client Details

Our client is a well‑established manufacturer supporting highly regulated, technology‑driven sectors, with a strong commitment to quality, innovation, and operational excellence. They offer a collaborative culture, long‑term stability, and meaningful opportunities to influence strategy, develop high‑performing teams, and contribute to products that make a significant impact.

Description

• Develop and implement the site quality strategy aligned with global quality standards and ISO 13485 requirements.
• Lead QA, QC, and Supplier Quality teams, driving performance, capability, and continuous development.
• Oversee compliance activities including CAPA, deviations, change control, document management, and audit readiness.
• Represent the site during customer and regulatory audits, ensuring robust responses and sustained compliance.
• Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve right‑first‑time performance.
• Strengthen supplier quality performance, including qualification, audits, and ongoing risk‑based monitoring.

Profile

• Bachelor's degree in Engineering, Science, or a related technical field; advanced degree or certifications preferred.
• 5-10+ years of quality leadership experience in medical device, biopharma, or life science manufacturing.
• Expertise with ISO 13485 and ISO 9001 quality systems; strong understanding of GxP.
• Proven success in site‑level leadership roles within regulated manufacturing environments.
• Experience leading internal/external audits and driving CAPA and continuous improvement programs.
• Strong communication, influencing, and team‑building skills with a hands‑on, pragmatic approach.

Job Offer

• Competitive salary range
• Comprehensive benefits package.
• Opportunities for professional growth and development.
• A supportive work environment focused on innovation and excellence.

If you are an experienced Sr. Quality Manager looking to advance your career in the business services industry, we encourage you to apply today!

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.