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Senior Quality Engineer - Medical Device - Hopkinton, RI

International Permanent USD100,000 - USD115,000 per year View Job Description
This role partners closely with engineering, manufacturing, and operations to ensure product and process quality across a regulated medical device environment. You'll lead validation, problem-solving, and continuous improvement initiatives with a strong focus on defect prevention and compliance.
  • Be a hands-on change agent driving continuous improvement on the floor
  • Own quality from validation through production in a regulated environment

About Our Client

This organisation is a well-established manufacturer operating in a highly regulated industry, known for its technical complexity and commitment to quality. The culture values collaboration, accountability, and people who enjoy making tangible improvements in how products are built and validated.

Job Description

  • Drive product and process quality using statistical tools, audits, and structured problem-solving methodologies
  • Lead and maintain process validations, including PFMEAs, OQ/PQ, PPAPs, FAIRs, and validation reports
  • Manage MRB activities, NCRs, and CAPA, ensuring effective corrective actions and follow-up
  • Analyse manufacturing and validation data to reduce variation, waste, and defects
  • Review and control internal and external changes, including customer specifications
  • Support ERP-related activities including route and BOM approvals
  • Lead and support software validation activities, including test cases and validation documentation
  • Investigate customer complaints using structured root cause analysis techniques
  • Support internal, customer, and registrar audits as required



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.

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/scientific discipline
  • 1-3 years' experience in a medical device manufacturing environment
  • Strong working knowledge of ISO 13485:2016 and familiarity with FDA CFR Part 820
  • Hands-on experience with process, product, and software validation
  • Strong analytical skills; experience with statistical tools (Minitab preferred)
  • Experience with ERP systems and a fast-paced manufacturing environment
  • Excellent written and verbal communication skills

What's on Offer

  • High-impact role with real ownership of quality and validation activities
  • Exposure across engineering, manufacturing, and operations
  • Opportunity to strengthen regulated industry expertise
  • Strong emphasis on continuous improvement and best practices
  • Stable environment with long-term growth potential
Contact
Taylor Rankin
Quote job ref
JN-052026-7028979

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Healthcare / Pharmaceutical
Location
International
Contract Type
Permanent
Consultant name
Taylor Rankin
Job Reference
JN-052026-7028979