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Validation Quality Engineer
Insight Global
7d
Saint Paul, MN, US
619 miles away

Job Type
Full-time
Job Description
Job Description Insight Global is seeking a Validation Quality Engineer to join one of our medical device clients to work on a class III device. The scope of the role is one specific, large PPAP (Production Part Approval Process) that must be completed by the end of September to support a regulatory submission that will be made by the customer in October. ~80% of the candidates time will be spent writing test method validation (TMV) protocols, executing them, and writing the summary reports; the same for process validation. Their validation knowledge needs to be at a level where the candidate can complete those assignments with very little hand holding from the team beyond initial orientation to the project. Most of the rest of the PPAP work is complete, but the remaining tasks will take up ~20% of the candidates time and will include activities like Measurement System Analysis (MSA) We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements - Process and validation remediation experience needed - Test method and change management process - At least 3 years of experience in quality and/or validation engineering - Medical device experience - Extreme attention to detail - Excellent documentation skills null 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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.