Quality Engineer

Jobs › Raynham, MA › Quality Engineer Insight Global Quality Engineer Raynham, MA Apply Job Description Insight Global is seeking a Quality Engineer (Process Validation) to support a leading medical device client in a highly regulated manufacturing environment. This role will focus on executing process validations (IQ, OQ, PQ) and providing hands-on support on the manufacturing floor to troubleshoot and resolve quality and process issues. The ideal candidate has a few years of validation experience, thrives in fast-paced production settings, and is comfortable collaborating cross-functionally to ensure compliant, efficient manufacturing operations. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements 1-5+ years of experience in medical device manufacturing or another highly regulated industry Hands-on experience executing process validations including

IQ, OQ, PQ

Strong understanding of

GMP, FDA, ISO

13485, and regulated quality systems Experience investigating non-conformances, deviations, and supporting CAPAs Experience supporting or executing change control activities Experience supporting new product introductions (NPI) Exposure to EU MDR validation assessment or rationalization Experience with PLM systems Background in orthopedic, casting, or implantable medical devices Active Filters Quality Engineer Raynham, MA Clear All Apply