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Quality Engineer : Columbia Heights, MN

Lancesoft Inc
Minneapolis, Minnesota, 55421, United States
March 21, 2017

Job Description:

Job Requirements:

• Must have Med Device Manufacturing and Quality experience

• 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)

• 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

• Adhere to the Medtronic Core Behaviours of Customer Focus, Candor, Trust and Respect, Courage, Accountability, and Passion to Win

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.

Physical Job Requirements

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions