We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Autoimmunity and Transfusion and transplant. In addition, 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.
In Werfen, we are, looking for a Quality Engineering Engineer, She/he is responsible to guarantee that the Standards under which the Quality System is based are aligned with the requirements of the different Regulations of the Countries and Organizations where Werfen Immunoassay sells the products. Assure that all products manufactured at Werfen Immunoassay are designed, manufactured and released according to established procedures. In addition this role works with specific manufacturing teams to drive continuous improvement of Quality within manufacturing – seeking defect rate reduction, increased manufacturing efficiency, reduced costs and enhanced customer satisfaction.
Knowledge & Experience:
• Required: Bachelor’s degree (diplomatura) in Chemistry, Biotechnology or other Sciences
• Valuable: Any additional degree higher than that required.
• Experience is required, 3 years in a similar position.
• Fluency in Office Tools (Excel & Word), and valuable basic knowledge in SAP
• Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking)
• Valuable knowledge on Quality Standards.
Key Accountabilities
• Review and approval of manufacturing and general procedures
• Development of Quality Improvement plan for manufacturing area of responsibility.
• Measurement and reporting of Quality KPIs and metrics for manufacturing area of responsibility.
• Change Management: evaluate the impact of the proposed changes and management of change control.
• Validation: Be able to establish a strategy to validate changes. Review and approve validation strategies and the corresponding documentation (protocol and report).
• Risk Assessment: perform, review and approve the risk assessment performed at Werfen OEM to evaluate the impact of changes and non-conformances in the final product.
• Participate in Internal and External Audits.
• Perform Quality Training to all personnel at Werfen Immunoassay.
• Management of Non-Conformities and CAPA's.
• Review of product Batch Record as needed.
Skills & Capabilities:
• Management of decisions under pressure.
• Methodical and well-organized person.
• Teamwork
• Time management skills
• Ability to express information clearly and concisely to the staff, ensuring their understanding.
• Ability to apply a systematic approach and constant control, follow-up and verification of the results.
• Ability to collaborate, participate and coordinate actively with working groups.
• Reflects values of Werfen in the quality of work and working relationship.
What we offer:
• A meaningful project that will impact the quality of laboratory medicine worldwide
• Multicultural and friendly team
• Exciting opportunities for professional development.
• Ongoing training
• Social benefits: Canteen, nursery check, Language training...
• Retirement Plan
Our Purpose: We contribute to the advancement of patient care around the world through innovative specialized diagnostics
JOIN US!