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Quality Engineer II - 53482519 - TT

Job Code: 53482519
Job Location: St Paul, MN
Category: Quality Engineering
Last Updated: 09/30/2016
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Job Description:
•Develop and maintain strong working relationship with functional groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)
•Remediate legacy supplier qualifications and manufacturing production line validations
•Review/prepare test plans and reports (qualification, validation) for assigned improvement activities.
•Support/participate in the CAPA process for resolution of issues and corrective actions.
•Provide technical assistance to suppliers/other resources performing qualification/validation testing. Assure the resolution of all issues raised during testing.  
Work with the Quality Management System and maintain compliance with corporate policies, FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines.
•BS/BA degree in engineering or science
•4+ years engineering experience  
•3+ years in Medical Device Industry
•Supplier quality and mfg. production quality experience
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 53482519TT
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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