Quality Engineering Engineer

We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Autoimmunity, and Transfusion and Transplant. We research, develop, and manufacture customized assays and biomaterials through our Immunoassay business line.

As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostics products.

We are looking for a Quality Engineering Engineer. She/he is responsible for ensuring that the Standards underpinning the Quality System align with the requirements of the various Regulations of the Countries and Organizations where Werfen Immunoassay sells its products. The role involves ensuring all products manufactured at Werfen Immunoassay are designed, manufactured, and released according to established procedures. Additionally, this role works with manufacturing teams to drive continuous improvement in Quality—aiming to reduce defect rates, increase manufacturing efficiency, reduce costs, and enhance customer satisfaction.

Knowledge & Experience:

• Required: Bachelor’s degree (diploma) in Chemistry, Biotechnology, or other Sciences.
• Valuable: Any additional higher degree.
• Experience: At least 3 years in a similar position.
• Proficiency in Office tools (Excel & Word); basic knowledge of SAP is valuable.
• Fluency in Spanish or Catalan; advanced English skills (reading and speaking).
• Valuable knowledge of Quality Standards.

Key Accountabilities:

• Review and approve manufacturing and general procedures.
• Develop Quality Improvement plans for manufacturing areas.
• Measure and report on Quality KPIs and metrics.
• Manage Change Control: evaluate the impact of proposed changes.
• Establish validation strategies, review, and approve validation documentation.
• Perform, review, and approve risk assessments related to changes and non-conformances.
• Participate in internal and external audits.
• Conduct Quality Training for all personnel.
• Manage Non-Conformities and CAPAs.
• Review product Batch Records as needed.

Skills & Capabilities:

• Decision-making under pressure.
• Methodical and organized approach.
• Teamwork and collaboration.
• Clear and concise communication skills.
• Systematic approach with follow-up and verification.
• Active participation and coordination within teams.
• Reflects Werfen's values in work quality and relationships.

What we offer:

• Impactful projects improving laboratory medicine worldwide.
• Multicultural and friendly team environment.
• Opportunities for professional development.
• Ongoing training programs.
• Social benefits: Canteen, nursery checks, language training, etc.
• Retirement Plan.

Our Purpose: We contribute to advancing patient care globally through innovative specialized diagnostics.

JOIN US!