Supplier Quality EngineeringProgram Leader Transfusion

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 7000 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. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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 Werfens 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.

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

Minimum Knowledge & Experience required for the position:

• Bachelors 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

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals 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 contactfor 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 7000 employees around the world comprise our Werfen team.