Quality Assurance Engineer III
Role: Quality Assurance Engineer III
Location: Boston, MA (hybrid)
Salary: $90,000 - $110,000
EPM is partnered with an establish medical equipment manufacuturer which is already revenue-generating and bringing in over $1B+ annually. They are looking to bring on a Quality Assurance Engineer III to join and lead their QE team in supporting the development, manufacture, and ongoing reliability of their medical devices. While this is a very established company, growth opportunity is a reality here - with the opportunity to become a Sr. Quality Engineer in the near future.
Qualifications:
- Strong experience and knowledge of process validation (IQ, OQ, PQ)
- Strong experience and knowledge working with both internal and external audits
- Knowledge and experience of ISO 13485
- Familiarity with root cause investigations, using tools such as 5 Why, Fishbone, FMEA.
- Proficiency in statistical tools such as Minitab and Gage R&R
Responsibilities:
- Partner with cross‑functional teams to provide quality guidance during development, manufacturing, and continuous improvement efforts.
- Contribute to investigations, root‑cause analysis, and implementation of corrective and preventive actions.
- Participate in risk‑based decision‑making, supporting assessment, mitigation, and ongoing evaluation of product and process risks.
- Support internal and external audits by preparing evidence, addressing observations, and promoting inspection readiness.
Benefits:
- Competitive compensation package
- Vision, dental, health insurance
- Sign-on bonus for relocating candidates
- 401K match
We invite motivated candidates who are passionate about quality and patient safety to apply and join a team dedicated to supporting reliable, compliant, and impactful medical device solutions.
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