Supplier Quality Engineer

Position : Supplier Quality Engineer

Location : Moundsview, MN - 55112

Duration : Long term contract

Other Requirement - ISO 13485 Certified Talents are requested by the client

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.