Supplier Quality Engineer

Katalyst HealthCares and Life Sciences

• $70K — $95K *
Minneapolis, MN 55407In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
2 months ago
Job Overview by Ladders

Qualifications

  • 5-7 years of experience in supplier quality in the medical device or regulated industry
  • Strong understanding of IQ/OQ/PQ validation processes
  • Hands-on experience with Client/CAPA handling and audit processes
  • Familiarity with risk management methodologies like FMEA
  • Ability to start immediately and work onsite

Responsibilities

  • Lead supplier transfer and qualification efforts
  • Execute validation protocols (Installation Qualification, Operational Qualification, Performance Qualification)
  • Manage and coordinate quality agreements with suppliers
  • Address Client/CAPA investigations and ensure effective resolution
  • Conduct thorough supplier audits to verify compliance
  • Implement risk management activities like FMEA and risk assessments

Benefits

  • Professional development opportunities
  • Collaborative work environment
  • Direct impact on product quality and regulatory compliance
  • Engagement in continuous improvement initiatives
  • Opportunity to work in a critical role within a regulated sector
Full Job Description
Job Summary:
  • We are seeking a Supplier Quality Engineer to support supplier transfer activities and ensure compliance with quality and regulatory standards.
  • The role involves validation execution, supplier quality management, and driving continuous improvement initiatives.
Roles & Responsibilities:
  • Lead supplier transfer and qualification activities
  • Execute validations (IQ/OQ/PQ)
  • Manage quality agreements with suppliers
  • Handle Client/CAPA investigations and resolutions
  • Conduct supplier audits and ensure compliance
  • Perform risk management activities (FMEA, risk assessments)
Experience:
  • Experience in supplier quality within medical device or regulated industry
  • Strong knowledge of IQ/OQ/PQ validations
  • Hands-on experience with Client/CAPA and audits
  • Familiarity with risk management processes
  • bility to work onsite and start immediately.
* Ladders Estimates

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