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Manufacturing Quality Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-02-19
Listing for:
Staftonic LLC
Full Time
position Listed on 2026-02-19
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer -
Manufacturing / Production
Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below
- Review and interpret DFMEAs and PFMEAs and ensure alignment with current manufacturing processes
- Identify inconsistencies between documented risk and actual process controls
- Support and execute IQ / OQ / PQ for manufacturing and supplier processes
- Troubleshoot manufacturing and quality issues impacting compliance and risk
- Support remediation activities related to FDA observations or warning letters.
- Participate in CAPA investigations and root cause analysis activities
- Bachelor’s degree in Engineering (Manufacturing, Mechanical, Biomedical, Chemical, or related)
- 5–8 years of Manufacturing Engineering or Quality Engineering experience in Medical Devices
- Strong statistical analysis experience (SPC, data trending, Minitab or similar tools)
- Hands‑on experience with process validation and manufacturing controls
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