Quality Manager - Medical Device - West Boylston, MA

About Our Client

This is a growing, technically focused manufacturing organization operating in a regulated environment where quality is central to the business. The company offers strong leadership visibility, hands‑on influence, and the opportunity to shape quality systems as the business continues to evolve.

• Own and continuously improve the Quality Management System in line with ISO 9001:2015 and ISO 13485 standards
• Serve as Management Representative, reporting directly to senior leadership on quality performance and compliance
• Lead internal audits, CAPA, management reviews, and customer complaint handling
• Partner with manufacturing and engineering teams to implement new testing criteria, assembly methods, and process improvements
• Establish and maintain product, process, and raw material quality standards across production
• Oversee supplier quality, including qualification, performance, and corrective actions
• Support new and transferred projects using APQP, PPAP, and IQ/OQ/PQ methodologies
• Lead and develop the Quality team through training, coaching, and performance management

MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

• Bachelor's degree with 5+ years of quality experience in a manufacturing environment
• Strong working knowledge of ISO 9001 and ISO 13485 standards
• Experience in medical device or highly regulated manufacturing environments
• Hands‑on expertise with SPC tools, metrology equipment, and GD&T
• Proven leadership experience managing and developing quality teams

• Senior, visible role with ownership of site‑wide quality strategy
• Opportunity to lead and shape quality systems in a regulated environment
• Strong cross‑functional influence across manufacturing, engineering, and leadership
• Hands‑on technical role with real decision‑making authority
• Stable business with long‑term growth and continuous improvement focus