Quality Engineering Engineer

Werfenlife SA.; Oviedo; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading company in specialized diagnostics is seeking a Quality Assurance Specialist in Oviedo. In this role, you will ensure compliance with quality standards, conduct audits, and lead improvement initiatives. This is an opportunity to impact laboratory medicine globally while working in a diverse environment and growing your skills through ongoing training.

Servicios

Ongoing training opportunities

Social benefits: Canteen

Nursery check

Private medical insurance

Retirement plan

Formación

• At least 3 years in a similar position.
• Fluency in Spanish or Catalan and advanced English skills required.
• Knowledge of Quality standards.

Responsabilidades

• Review and approve manufacturing and general procedures.
• Develop Quality Improvement plans and manage Change Control.
• Conduct audits and Quality Training for personnel.

Conocimientos

Decision-making under pressure

Organized

Clear communication

Collaboration

Educación

Bachelor's degree in Chemistry, Biotechnology, or other Sciences

Higher degree (valuable)

Herramientas

Excel

Word

SAP

Descripción del empleo

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 the various Regulations of the Countries and Organizations where Werfen immunoassay sells its products. The role involves ensuring that all products manufactured at Werfen Immunoassay are designed, manufactured, and released according to established procedures. Additionally, this role collaborates with manufacturing teams to drive continuous quality improvement—aiming to reduce defect rates, increase manufacturing efficiency, reduce costs, and enhance customer satisfaction.

Responsibilities

Key Accountabilities

• Review and approve manufacturing and general procedures.
• Develop Quality Improvement plans for the manufacturing area of responsibility.
• Measure and report on Quality KPIs and metrics for the manufacturing area.
• Manage Change Control by evaluating proposed changes and their impacts.
• Establish validation strategies, review, and approve validation protocols and reports.
• Perform, review, and approve risk assessments related to changes and non-conformances.
• Participate in Internal and External Audits.
• Conduct Quality Training for all personnel at Immunoassay.
• Manage Non-Conformities and CAPAs.

Review product Batch Records as needed.

Internal Networking

• Main interactions are with Operations and Quality Control teams.

Qualifications

Minimum Knowledge & Experience

Required: Bachelor's degree (Diplomatura) in Chemistry, Biotechnology, or other Sciences. Relevant skills and work experience may substitute the degree.

Valuable: Any additional higher degree.

Experience:

Required: At least 3 years in a similar position.

Knowledge:

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

Skills & Capabilities

• Decision-making under pressure.
• Methodical, organized, and team-oriented.
• Clear and concise communication skills.
• Systematic approach with ongoing control, follow-up, and verification.
• Active collaboration and coordination with teams.
• Alignment with Werfen’s values in work quality and relationships.

Travel Requirements

Not required.

What We Offer

• A meaningful project impacting laboratory medicine worldwide.
• A multicultural and friendly team.
• Ongoing training opportunities.
• Social benefits: Canteen, nursery check, training, private medical insurance, retirement plan.

If you are interested in continuous learning and daily challenges, we encourage you to submit your resume or CV.

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

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