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Quality Engineer
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Entegee, Inc.
Acton, MA (In Person)
$150,800 Salary, Full-Time
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Job Description
Quality engineering role responsible for medical device quality support, PFMEA activities, design review support, DHF documentation, and test method validation. Job Requirements Bachelor's degree 5 or more years of industry experience Medical device industry experience Quality engineering experience Strong PFMEA experience Experience supporting Design History File documentation Experience supporting design reviews Ability to work onsite Monday through Friday Preferred Skills Test method validation experience IQ, OQ, and PQ validation experience Experience supporting medical device development or manufacturing quality activities Experience reviewing quality documentation for design and process compliance Experience working with cross-functional engineering, quality, and manufacturing teams Job Responsibilities Support quality engineering activities within the medical device industry Lead or support PFMEA development, review, and updates Support Design History File documentation activities Support design reviews for medical device products or processes Review quality documentation for accuracy, completeness, and compliance Support test method validation activities Support IQ, OQ, and PQ validation activities as needed Identify quality risks and support mitigation activities Support process quality improvements related to medical device manufacturing or development Maintain quality engineering documentation according to applicable procedures