Supplier Quality Engineer

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.

The Supplier Quality Engineer plays a critical role in our Quality System. Biokit is looking for a professional fully integrated into the Supplier Quality Department to manage all aspects related to suppliers. The mission of this position is to ensure that approved Direct and Indirect Suppliers comply with internal procedures and applicable IVD (In Vitro Diagnostics) industry standards, guaranteeing the highest quality in our final products.

Key Accountabilities

• Change Management: Evaluate the impact of proposed internal changes and supplier change notifications.
• Validation: Establish change validation strategies; review and approve validation documentation (protocols and reports).
• Risk Assessment: Conduct, review, and approve risk assessments performed at Biokit to evaluate the impact of changes on the final product.
• Audits: Act as an Internal Auditor and Supplier Auditor, and participate in External Audits.
• Supplier Compliance: Ensure Direct Suppliers and Indirect/Service Suppliers comply with applicable quality standards.
• Supplier Evaluation: Execute the approval and ongoing performance evaluation of Indirect/Service Quality Suppliers.
• Training: Deliver Quality Training to personnel across Biokit.
• Stakeholder Management: Serve as an interface with partners and suppliers for all required Quality activities.
• Quality Issues Resolution: Manage Non-Conformities, CAPAs, Supplier Complaints, and SCARs.

Networking & Key Relationships

Interactions determined by department needs, including:

• Procurement
• Technical Support
• Quality Operations

Minimum Requirements & Qualifications

Education

• Bachelor's Degree (Diplomatura/Grado) in Chemistry, Biotechnology, or related Life Sciences (relevant skills and work experience may be considered in lieu of degree).
• Postgraduate degrees or higher qualifications are a plus.

Experience: Minimum of 3 years of experience in a similar supplier quality role.

Tools & Software: Proficiency in Microsoft Office (Excel & Word). Basic working knowledge of SAP is valued.

Languages: Professional fluency in Spanish or Catalan. Advanced proficiency in English (both spoken and written).

Regulatory & Standards: Strong knowledge of Quality standards applicable to the IVD sector.

Skills & Competencies

• Sound decision-making under pressure.
• Methodical, structured, and well-organized approach to tasks.
• Strong teamwork and collaborative mindset.
• Effective time management and prioritization skills.
• Excellent communication skills, with the ability to convey complex information clearly and concisely across teams.
• Systematic approach with continuous tracking, follow-up, and verification of deliverables.
• Active alignment with Werfen values in everyday work and professional relationships.

Travel Requirements

• Up to 15% travel.

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

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

www.werfen.com