Supplier Quality Engineer - W2 Role - Local profiles needed

  • Mounds View, MN
  • Posted 15 hours ago | Updated 15 hours ago

Overview

On Site
Depends on Experience
Contract - W2

Skills

Medical Devices
QA
Test
ISO 13485 Certified

Job Details

Job Title: Supplier Quality Engineer
Location: Mounds View, CA
Duration: Long Term Contract

Job Description:
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 Medtronic s quality standards and regulatory requirements.

Key Responsibilities:
Supplier Qualification & Management:
Qualify suppliers in accordance with company standards.
Manage and maintain the Approved Supplier List (ASL) in compliance with Medtronic 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 Medtronic 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 Medtronic s commitment to reliability.
Issue Resolution:
Collaborate with suppliers to address SCAPA/NCR issues in compliance with company standards.

Qualifications:
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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