Supplier Quality Engineer

6 days ago

minneapolis, United States EPM Scientific Full time

Job Summary:

EPM Scientific is collaborating with a premier medical device company to recruit a skilled Quality Engineer for a 12-month onsite contract role in Minneapolis, MI. This opportunity offers a competitive hourly rate and an immediate start, targeting professionals with mid-level experience in medical device quality engineering, specifically in product engineering, change control, CAPA, and supplier quality.


Key Responsibilities:

  • Oversee product engineering quality processes, ensuring alignment with industry standards and regulatory requirements for medical devices.
  • Utilize Windchill PLM (Product Lifecycle Management) to manage product data, change control, and document management across the product lifecycle.
  • Drive effective CAPA (Corrective and Preventive Actions) processes to address quality issues, including root cause analysis, corrective action implementation, and verification of effectiveness.
  • Collaborate closely with suppliers to ensure compliance with quality standards and regulatory requirements, conducting audits and addressing any quality issues.
  • Manage and execute change control processes, ensuring thorough documentation and approval of all changes impacting product quality.
  • Maintain compliance with ISO standards and FDA regulations, contributing to the continuous improvement of quality management systems.


Qualifications:

  • Mid-level experience (3-5 years) in Quality Engineering within the medical device industry.
  • Proven expertise in product engineering, CAPA, change control, and supplier quality processes.
  • Strong familiarity with Windchill PLM system for product lifecycle management.
  • Medical device manufacturing experience is highly preferred.
  • Solid understanding of industry regulations, including ISO and FDA standards.
  • Strong analytical, problem-solving, and communication skills to collaborate effectively with cross-functional teams.


Work Schedule:

  • 40 hours per week with onsite presence in Minneapolis, MI, required 3 days per week.


Why Apply?

This position offers the chance to work with a leading medical device company in a well-established role focused on ensuring the highest quality standards for life-saving products. With attractive hourly compensation and the support of a renowned recruitment team, this is an exceptional opportunity to advance your career in quality engineering.

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