Quality Engineer

Lead Quality Initiatives

Lead quality initiatives on life-changing medical device products. High-impact role with visibility across operations, engineering, and leadership.

About Our Client

Our client is a well-established manufacturer serving highly regulated industries where quality, innovation, and operational excellence are critical to success. They offer a collaborative environment with strong leadership support, ongoing process improvement initiatives, and opportunities for career growth and professional development.

Job Description

Support and maintain compliance with quality management systems, regulatory requirements, and internal operating procedures. Partner with manufacturing and engineering teams to ensure product quality throughout production. Lead and support regulatory inspections, audits, investigations, and customer quality inquiries. Review and approve engineering changes including BOMs, drawings, procedures, specifications, FMEAs, and control plans. Develop, execute, and document validation protocols for test methods, manufacturing processes, and quality systems. Drive continuous improvement efforts utilizing quality tools, statistical analysis, and process improvement methodologies. Lead risk management activities and maintain product risk assessments. Create and implement incoming, in-process, and final inspection procedures to ensure product compliance. Investigate nonconformances, manage corrective and preventive actions (CAPA), and ensure effective root cause resolution. Lead complaint investigations and trend analysis related to product quality and customer feedback. Work cross-functionally with suppliers, manufacturing teams, and engineering groups to resolve quality issues. Support new product introductions, product transfers, and quality planning activities. Provide guidance and leadership to quality inspectors and technicians as needed.

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 in Engineering or a related technical discipline preferred. Alternatively, 2 to 5 years of quality engineering experience within a regulated manufacturing environment. Experience in medical device manufacturing strongly preferred. Working knowledge of FDA regulations, ISO 13485, ISO 14971, MDSAP, and other relevant quality standards. Experience using quality engineering tools and methodologies such as CAPA, FMEA, DOE, SPC, and validation activities. Strong analytical and problem-solving skills with the ability to identify root causes and implement corrective actions. Experience with statistical analysis tools, including Minitab. Excellent communication skills and the ability to collaborate effectively with internal and external stakeholders. Ability to manage multiple priorities while maintaining accuracy and attention to detail.

What's on Offer

Make a direct impact on products that support critical healthcare applications. Work in a highly visible quality role with broad cross-functional exposure. Gain hands-on experience with advanced quality systems, validations, and regulatory compliance. Join an organization committed to continuous improvement and operational excellence. Strong opportunity for career advancement within a growing manufacturing environment.

Job Summary

Sector: Engineering & Manufacturing

Sub Sector: Quality, Technical

Industry: Industrial / Manufacturing

Where: Sturbridge

Contract Type: Permanent

Consultant Name: Kyle Perry

Job Reference: JN-092026-7102245