Quality Manager - Medical Device - Westerly, RI

Quality Leader

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.

Minimum 10 years of quality, compliance, or quality management experience within a regulated manufacturing environment. Strong knowledge of ISO 13485, ISO 9001, quality systems management, and regulatory compliance requirements. Proven leadership experience managing Quality Assurance, Quality Control, compliance, or continuous improvement teams. Experience with CAPA programs, NCR investigations, customer complaint management, supplier quality, and auditing processes. Strong analytical skills with the ability to interpret quality metrics, statistical data, and business performance trends. Experience conducting failure analysis, root cause investigations, and implementing corrective and preventive actions. Working knowledge of Lean Manufacturing, Six Sigma methodologies, and continuous improvement practices. Proficiency with Microsoft Office and statistical analysis tools such as Minitab or similar software. Bachelor's degree in Engineering or a related technical discipline preferred. ASQ certifications such as CMQ/OE, CQE, or CQA are highly desirable.

Lead enterprise-level quality and compliance initiatives with direct business impact. Influence company strategy through quality leadership and performance improvement programs. Work in a highly visible role partnering with senior leadership and cross-functional teams. Drive meaningful process improvements using Lean, Six Sigma, and advanced quality methodologies. Join a stable organization that values innovation, continuous improvement, and professional growth.