Supplier Quality Engineer

Moundsview, MN

30+ days ago

Job Description

Mandatory : ISO 13485 Certified

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.
Key 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.

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.

Numbers & Facts

Location	Moundsview, MN
Industry	Other/Not Classified
Company Size	100 to 499 employees

Skills

Communication Skillsunmatched
Control Systemsunmatched
Corporate Complianceunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Document Controlunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
Healthcareunmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Medical Equipmentunmatched
Problem Solving Skillsunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Validationunmatched
Procurement Managementunmatched
Product Strategyunmatched
Production Part Approval Process (PPAP)unmatched
Quality Assuranceunmatched
Quality Assurance Methodologyunmatched
Quality Engineeringunmatched
Quality Metricsunmatched
Receiving Inspectionunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Release Management/Engineeringunmatched
Requirements Managementunmatched
Resolve Customer Issuesunmatched
Technical Supportunmatched
Validation Documentationunmatched
Validation Testingunmatched

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