Supplier Quality Engineering/Program Leader - Transfusion

Werfenlife SA.; Norcross, Northern (GA, KY); Hybrid; USD 125,000 - 180,000; Full time

Job summary

Werfen is seeking a Supplier Quality Engineering/Program Leader at the Norcross, GA site to own the supplier quality program and drive compliance with ISO 13485, FDA QMSR, and MDSAP. The role spans supplier qualification, audits, CAPAs, and management review reporting in a highly matrixed organization.

The ideal candidate has 8+ years in quality with 5+ years in supplier quality within medical devices, and a strong track record in audits and supplier risk management.

Qualifications

• 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 deviations, investigations, complaints, and effectiveness verification.
• Evaluate supplier change notifications and determine quality, validation, and regulatory impact.
• Provide quality leadership and oversight for Incoming Inspection, including risk-based inspection strategies and optimization.
• Represent Supplier Quality during FDA inspections, ISO 13485/MDSAP audits, customer audits, and internal audits.

Skills

Quality Leadership

Supplier Quality

Regulatory Compliance

Auditing

ISO 13485

Education

Bachelor's degree in Engineering

Job description

Supplier Quality Engineering/Program Leader - Transfusion

Country

United States

Shift

1st

About the Position

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

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.

Responsibilities

Key Accountabilities

• 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
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions

Qualifications

Minimum Knowledge & Experience required for the position:

• 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

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please [e-mail] assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.