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
Employment Type : Full Time
Experience : years
Vacancy : 1