Sr. Quality Engineer

1 month ago

Maple Grove, United States Medix™ Full time

Looking for a Sr. Quality Engineer with prior experience to work for a leading medical device company in Maple Grove, MN. This would be a contract position roughly 8 to 10 months and up to a year max. Can get someone started ASAP or after a proper notice.


Position Summary:

The Senior Quality Engineer is tasked with enhancing quality, production, and processing methods and controls within manufacturing to achieve operational excellence. This role demands the ability to cultivate and sustain strong relationships with manufacturing engineering and production teams, facilitating effective communication across various organizational levels. The Senior Quality Engineer collaborates closely with Design Assurance, Sustaining Engineering, and Manufacturing, playing a vital role in supporting daily operations.


Principal Responsibilities:

  • Determine test requirements, methods, sample sizes, and statistical analysis for qualification/verification studies in manufacturing.
  • Develop and manage verification, validation, and qualification plans and reports for manufacturing processes.
  • Lead non-conformance investigations related to component failures, finished goods failures, and product returns, including risk analysis, root cause determination, and corrective action recommendations.
  • Support customer complaint investigations, including product/record analysis, health risk assessments, CAPA identification, and report generation.
  • Coordinate Change Impact Assessment activities.
  • Contribute to site initiatives such as Cost of Quality, Defects Per Million, and Continuous Improvement Projects.
  • Mentor and train engineers and production team members.
  • Reduce manufacturing process defects through implemented corrections.
  • Update manufacturing or quality SOPs and other related documentation as needed.
  • Ensure adherence to company policies and procedures.
  • Foster effective working relationships with colleagues.
  • Proactively identify and eliminate potential manufacturing process defects.
  • Demonstrate high proficiency in functional areas.
  • Define, plan, and execute major projects related to product quality and regulatory compliance.
  • Enforce company policies and procedures, taking timely corrective action with HR assistance when necessary.


Education and Experience Requirements:

  • Bachelor's degree in a Science or Engineering discipline.
  • At least 5 years of Quality Engineering experience.
  • Experience in a manufacturing environment, preferably within a regulated or medical devices industry.

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