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 ensure that the Standards underpinning the Quality System align with the requirements of various Regulations in the countries and organizations where Werfen immunoassay sells its products. The role involves ensuring all products manufactured meet established procedures and working with manufacturing teams to drive continuous quality improvements—aiming for defect reduction, increased efficiency, cost reduction, and enhanced customer satisfaction.

Responsibilities

Key Accountabilities

• Review and approve manufacturing and general procedures.
• Develop Quality Improvement plans for the manufacturing area.
• Measure and report on Quality KPIs and metrics.
• Evaluate the impact of proposed changes and manage change control processes.
• 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 Immunoassay personnel.
• Manage Non-Conformities and CAPA processes.

Review product Batch Records as needed.

Internal Networking

• Main interactions with Operations and Quality Control teams.

Qualifications

Minimum Knowledge & Experience

Required: Bachelor's degree (Diplomatura) in Chemistry, Biotechnology, or related sciences. Relevant skills and work experience may substitute for degree. Additional higher degrees are advantageous.

Experience: At least 3 years in a similar role.

Knowledge:

• Proficiency in Office tools (Excel & Word); basic knowledge of SAP is valuable.
• Fluency in Spanish or Catalan, and advanced English skills.
• Knowledge of Quality standards.

Skills & Capabilities

• Decision-making under pressure.
• Methodical, organized, and team-oriented.
• Effective communication skills.
• Systematic approach with follow-up and verification skills.
• Ability to collaborate and coordinate within teams.
• Demonstrates Werfen's values in work quality and relationships.

Travel Requirements

Not required.

What We Offer

• A meaningful project impacting laboratory medicine worldwide.
• Multicultural and friendly team environment.
• Ongoing training opportunities.
• Social benefits including canteen, nursery check, training, private medical insurance, and retirement plan.

If you are eager to learn and face daily challenges, we encourage you to submit your resume or CV.

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

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