Supplier Quality Engineer
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Job Location:
Mounds View, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Supplier Quality Engineer
Location- Mounds View CA
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 Medtronics 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 Medtronics 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 Medtronics commitment to reliability.
- Issue Resolution:
- Collaborate with suppliers to address SCAPA/NCR issues in compliance with company standards.
Qualifications:
- Bachelors 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
#NOBLE-NON-IT
Key Skills
- Project / Program Management
- Change Management
- Succession Planning
- Procurement
- Program Management
- ISO 9001
- Lean Six Sigma
- Quality Systems
- Quality Management
- Supplier Management
- HACCP
- As9100
