Quality Manager - Medical Device - West Boylston, MA

West Boylston, Massachusetts Permanent USD110,000 - USD120,000 per year View Job Description
This Quality Manager will lead and maintain a robust Quality Management System, ensuring compliance with ISO standards while driving continuous improvement across manufacturing and supplier quality. Acting as Management Representative, you'll partner closely with leadership and production teams to ensure product quality, regulatory compliance, and operational excellence.
  • Own end‑to‑end quality strategy in a regulated medical environment
  • Lead, influence, and elevate quality across the entire organization

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.

Job Description

  • 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 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.

The Successful Applicant

  • 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



What's on Offer

  • 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



Contact
Emma White
Quote job ref
JN-052026-7018461

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Location
West Boylston
Contract Type
Permanent
Consultant name
Emma White
Job Reference
JN-052026-7018461