Summary:Supplier Quality Engineer is responsible for ensuring suppliers deliver quality materials, components, and services in compliance with regulatory and organizational requirements within the medical device industry.
Roles & Responsibilities: - Ensure suppliers consistently deliver quality parts, materials, and services meeting Healthcare requirements.
- Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
- Perform product and feature-level quality impact assessments and maintain necessary documentation.
- Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
- Conduct supplier risk segmentation and maintain risk profiles.
- Facilitate Supplier Quality Agreements and conduct supplier audits.
- Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
- Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
- Route documentation in PLM systems and follow up for approvals and release.
- Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.
Education & Experience: - Bachelor's degree in engineering, Technical, or Scientific discipline.
- Minimum 5 to 8 years of experience in Supplier Quality or related roles within the Medical Device industry.
- Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
- Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA)
- Strong analytical and problem-solving skills.
- Excellent communication and stakeholder management abilities.
- Ability to work collaboratively with cross-functional and global teams.
- Proficiency in PLM systems and quality documentation tools.
