Quality Manager - Medical Device - Stonington, CT

• Serve as the quality leader across multiple business divisions, ensuring consistent quality standards and best practices.
• Maintain, improve, and oversee Quality Management Systems in compliance with ISO 13485, ISO 9001, and applicable regulatory requirements.
• Act as the Management Representative for quality systems and present quality performance metrics during management reviews.
• Lead Quality Assurance and Quality Control teams, providing guidance, direction, and performance management support.
• Develop quality objectives, strategic initiatives, and KPI programs that support continuous improvement and business growth.
• Analyze quality data, prepare statistical reports, and communicate trends and improvement opportunities to leadership teams.
• Oversee product testing, reliability programs, failure analysis investigations, and corrective action processes using methodologies such as 8D.
• Drive Lean Manufacturing and Six Sigma initiatives to enhance quality performance, reduce defects, and improve operational efficiency.
• Manage customer complaints, non-conformance reporting (NCR), CAPA programs, supplier quality activities, and audit readiness efforts.
• Lead internal, customer, supplier, and registrar audits while ensuring all controlled documentation remains compliant and current.
• Partner with Engineering, Operations, and leadership teams to ensure customer expectations and regulatory requirements are consistently met.
• Support software validation activities and ensure quality processes remain effective, scalable, and audit-ready.

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.