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Quality Engineer - 53321069 - SB

Job Code: 53321069
Job Location: Columbia Heights, MN
Category: Quality Engineering
Last Updated: 09/20/2016
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Job Description:
• Provide comprehensive support to Operations in all areas of production quality assurance.
• Provide Quality support for the manufacture of legacy products. Support includes process improvements, product non-compliance analysis, and process changes.
Responsibilities include:
• Assure assigned product lines and manufacturing processes are to the highest quality and are compliant to internal and external regulations such as QSR 820 and ISO13485.
• Partner with manufacturing engineer to provide day-to-day support of assigned product lines. Actively participate in team meetings and daily status meetings. Provide support to the actual manufacturing line within the Clean Environmental Area.
• Lead or actively participate in addressing issues that affect the quality of the product and/or the manufacturing lines, such as analysis and disposition of non-conforming products. Identify opportunities for improvement of the product and/or the process.
• Actively participate in audits / assessments of the manufacturing operations, and recommends corrective / preventive actions and process improvements.
• Applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities.
• Works with cross-functional groups to implement new products.
• Works with minimal supervision.
Basic Qualifications -
• Bachelor’s degree in Engineering discipline.
• Minimum 2 to 4 years quality assurance experience in a GMP environment or highly regulated industry with BS Degree. Minimum 0 to 2 years’ experience with Master’s Degree.
• Experience working in a team environment.
• Effective verbal and written communication, analytical, influencing and interpersonal skills.
• Must be able to communicate at all levels and across company lines.
• PC skills, word processing, spreadsheets, project management, etc. Basic Statistical Knowledge and Application
• Must have Med Device Manufacturing and Quality experience
• Candidates are local.
• Experience in the medical industry
• Work experience outside of school work
• A min of two to three years of work experience
• With a graduate degree (no interns)
Desired/Preferred Qualifications
• ASQC certification.
• Master’s degree in engineering discipline.
• 4 or more years of quality assurance experience in a GMP, disposable medical device environment.
• Molding and software experience.
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 53321069SB
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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