Quality Engineer
Insight Global
Job Description
Insight Global is seeking an experienced, highly skilled Quality Engineer to support an established medical supply client out of Chicago, IL. The Quality Engineer will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.
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 View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
Skills and Requirements
3-5+ years of experience as a Quality Engineer, Design Engineer, or Quality System Engineer within medical devices, pharmaceutical, or regulated healthcare manufacturing.
Strong working knowledge of 21 CFR Part 820 and/or ISO 13485
Hands on experience supporting Device Master Record (DMR) and Design History Files (DHF), or similar risk management design maintenance, execution, or remediation.
Familiarity with Corrective Action Preventative Action (CAPA)
Skills: Adaptive to change, cross-functionally collaborative, strong time management skills, independent, problem solver, self-motivated
Systems: Reliance or similar QMS
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