Quality Engineering 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 Immunoassay 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.

Overview

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 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.

Responsibilities

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 Biokit 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 Immunoassay.
• Management of Non-Conformities and CAPA's.

Review of product Batch Record as needed.

Internal Networking

Qualifications

Minimum Knowledge & Experience required for the position

Required : Bachelor's degree (Diplomatura) in Chemistry, Biotechnology or other Sciences.

Degree may be substituted by relevant skills and work experience.

Valuable : Any additional degree higher than the required.

Years of experience

Required : 3 years in a similar position.

Min knowledge

Software : Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAP.

Language : Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).

Standards : Knowledge of Quality standards.

Skills & Capabilities

Travel Requirements

Not Required

What we offer

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.

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