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Quality Engineer
hace 2 semanas
Werfen is a global leader in specialized diagnostics, operating directly in over 30 countries and reaching more than 100 territories worldwide through distributors.
We develop, manufacture, and distribute integrated solutions — including systems, reagents, automation, and software — for use primarily in hospitals and clinical laboratories.
At Werfen, we are driven by innovation, precision, and collaboration. Our people are at the heart of everything we do, committed to advancing patient care through excellence in science and technology.
Your Mission
The mission of this position is 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 Biokit sells the products. Additionally, you will assure that all products manufactured at Biokit are designed, manufactured and released according to established procedures.
This role will work 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.
Main Responsibilities
- Review and approval of manufacturing and general procedures.
- Change Management: Evaluate the impact of the proposed changes and management of change control.
- Validation: Establish a strategy to validate changes, and review and approve validation strategies and the corresponding documentation (protocol and report).
- Risk Assessment: Perform, review, and approve the risk assessment performed at Biokit to evaluate the impact of changes and non-conformances in the final product.
- Management of Non-Conformities and CAPA.
- Develop a Quality Improvement plan for the manufacturing area of responsibility.
- Measurement and reporting of Quality KPIs and metrics for the manufacturing area of responsibility.
- Participate in Internal and External Audits.
- Perform Quality Training to all personnel at Biokit.
- Review of product Batch Record as needed.
Requirements
- Education: Bachelor's degree (Diplomatura) in Chemistry, Biotechnology or other Sciences.
(Degree may be substituted by relevant skills and work experience)
. - Experience: 3 years in a similar position.
- Standards: Knowledge of Quality standards.
- Languages: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).
- Software: Fluency in Office Tools (Excel & Word). Basic knowledge in SAP is valuable.
Skills & Capabilities:
- Methodical and well-organized person.
- Teamwork and the ability to collaborate actively with working groups.
- Time management skills and management of decisions under pressure.
- Ability to apply a systematic approach and constant control, follow-up and verification of the results.
What we offer
- Join a young and collaborative team in an international environment.
- Hybrid work model: 3 days onsite + 2 days remote.
- Competitive benefits package: health insurance, pension plan, on-site cafeteria, parking, and professional development programs.
If you're passionate about Quality and continuous improvement, we'd love to hear from you
Apply now or get in touch to learn more about this opportunity.
