Medical Device Quality Lead

3 weeks ago

Minneapolis, Minnesota, United States Baxter Full time

Baxter is a world leader in medical devices, dedicated to saving and sustaining lives. As a Principal Engineer, you will play a key role in ensuring the quality of our products.

Our team is responsible for developing and implementing design plans, ensuring compliance with regulatory requirements and industry standards.

We are looking for an experienced professional with a strong background in Quality Engineering, who can provide quality oversight and mentorship to project teams.

In this role, you will have the opportunity to analyze manufacturing data, reports, statistics, and documentation to identify and address quality issues and process improvements.

Your Responsibilities:

  • Develop, review, and approve Design History File (DHF), Design Master Record (DMR), risk management, verification, validation, and other product development documents.
  • Ensure compliance to applicable Baxter policy, procedures, and regulations.
  • Provide direction and critical reviews for Development Planning, Design Inputs, Design Verification and Validation, Peer Technical and Design Reviews, Risk Management, and Labeling review.
  • Collaborate with Baxter plant, external partners, and corporate groups to transfer new and improved products.
  • Analyze manufacturing data, reports, statistics, and documentation to identify and address quality issues and process improvements.
  • Offer mentorship to project personnel regarding the appropriate application of design, statistical, and analytical tools.
  • Lead CAPA related activities as appropriate.
  • Monitor and report on critical metrics for CAPA during monthly governance meetings.
  • Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes.
  • Compile trending information from quality inputs (nonconformance, FCA, complaints, MDR, etc.) using Microsoft Excel for sustaining products organization.
  • Prepare and issue monthly PQDR (product quality data reports) based on information analysis.
  • Support both internal and external audits.

What we offer:

  • A competitive salary range of $104,000 to $143,000 annually, depending on location, skills, and experience.
  • A comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
  • The opportunity to work with a world-leading medical devices company.

About Baxter:

Baxter is a leading medical devices company that is committed to saving and sustaining lives. We offer a collaborative and dynamic work environment, where you can grow your career and make a meaningful contribution to our mission.

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