Supplier Quality Engineering/Program Leader - Transfusion
About The Position
The Supplier Quality Engineering/Program Leader serves as the technical leader and program owner for the Supplier Quality Management Program at the Norcross manufacturing site. This position provides enterprise leadership for supplier quality strategy, governance, and compliance, ensuring suppliers consistently meet Werfen's quality, regulatory, and business requirements. Working within a highly matrixed environment, this leader influences senior leaders across Procurement, Supply Chain, Operations, Manufacturing, R&D, Regulatory Affairs, Legal, and Quality without direct authority. The role owns the complete supplier lifecycle, including supplier qualification, approved supplier governance, supplier performance monitoring, supplier audits, supplier quality events, supplier quality agreements, supplier change management, incoming inspection oversight, management review reporting, and supplier quality representation during customer and regulatory inspections.
Requirements
- Bachelor's degree in Engineering or related technical discipline.
- Minimum 8 years of progressive Quality experience, including at least 5 years leading Supplier Quality in a regulated medical device or IVD environment.
- Demonstrated expertise in ISO 13485, FDA QMSR, supplier lifecycle management, supplier auditing, supplier risk management, and quality systems
Responsibilities
- Own supplier qualification, approval, onboarding, periodic review, probation, suspension, and disqualification decisions.
- Develop and execute the Supplier Quality strategy aligned with ISO 13485, FDA QMSR, MDSAP, and global regulatory requirements.
- Own and maintain the Approved Supplier List and supplier risk classifications.
- Lead supplier audits, supplier development activities, and corrective action follow-up.
- Own all supplier quality events including SCARs, supplier CAPAs, supplier-related devia-tions, investigations, complaints, and effectiveness verification.
- Evaluate supplier change notifications and determine quality, validation, and regulatory impact.
- Own the development, negotiation, implementation, and maintenance of Supplier Quality Agreements while partnering with Procurement and Legal.
- Provide quality leadership and oversight for Incoming Inspection, including risk-based in-spection strategies and optimization.
- Represent Supplier Quality during FDA inspections, ISO 13485/MDSAP audits, customer audits, and internal audits.
- Present supplier quality performance, risks, trends, and improvement initiatives during Management Review.
- Performs other duties and responsibilities as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
