JD- Supplier Quality Engineer
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.
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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