Supplier Quality engineer

2 weeks ago

Mounds View, Minnesota, United States Katalyst CRO Full time

Summary
We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualification, PPAP documentation, and process validation. This role is critical in ensuring that suppliers meet Healthcare's quality standards and regulatory requirements.

Roles & Responsibilities

  • Supplier Qualification & Management:
  • Qualify suppliers in accordance with company standards.
  • Manage and maintain the Approved Supplier List (ASL) in compliance with Healthcare's purchasing control procedures.
  • PPAP Documentation & Execution:Manage and release all PPAP deliverables including Control Plans, MSA, PFMEA, FAI, etc., within the document control system.
  • Support PPAP execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies.
  • Inspection & Test Method Validation:
  • Define Receiving Inspection requirements.
  • Validate test methods in alignment with internal Healthcare procedures.
  • Cross-Functional Collaboration:
  • Work with cross-functional teams to develop and implement product acceptance sampling strategies.
  • Deploy supplier quality tools such as PFMEA, MSA, control plans for both new and legacy products.
  • Technical Support & Quality Assurance:
  • Provide technical assistance to suppliers throughout the product/process qualification lifecycle.
  • Ensure delivery of high-quality parts, materials, and services to prevent defects and support Healthcare's commitment to reliability.
  • Issue Resolution:
  • Collaborate with suppliers to address SCAPA/Client issues in compliance with company standards.

Education & Experience

  • Bachelor's degree in Engineering or related field.
  • Minimum 4+ years of experience in supplier quality engineering within the medical device industry.
  • ISO 13485 Certified Talent preferred by client.
  • Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans.
  • Familiarity with FDA and ISO 13485 standards.
  • Excellent communication and problem-solving skills.
  • Ability to work independently and in cross-functional teams.

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