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.

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.

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

Desired/Preferred Qualifications

• 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.

To know more about this opportunity, please contact:

Sagar Rathore

Sagar.rathore(at)collabera.com

630-485-2166