Quality Engineer

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.

• 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.

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 Masters 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 Behaviors of Customer Focus, Candor, Trust and Respect, Courage, Accountability, and Passion to Win

• ASQC certification.

• Masters degree in engineering discipline.

• 4 or more years of quality assurance experience in a GMP, disposable medical device environment.

• Molding and software experience.