Quality Systems 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. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.

JOB SUMMARY

The Quality Systems (QS) Engineer is responsible for maintaining the core Quality Management

System (QMS) processes, including Document Control, Change Control, Internal Audit and

Training Management, and ensure the company is compliant with all applicable regulations and

standards. The QS Engineer operates with a high degree of autonomy in the planning,

coordination and exectuion of audits, and, upon qualification through the internal auditor

qualification program, is authorized to conduct internal audits independently. The role serves

also as a subject matter experts (SME) for the QS processes, providing technical guidance and

support across the organization. In addition, the QS Engineer actively contributes to the

continual improvement of the QRA function and supports the effective management of Non-

conformance, Corrective and Preventive Actions (CAPA), and other quality system improvement

initiatives.

Key Accountabilities

• Organize and coordinate internal and external audits, including planning, execution and

follow-up activities.

• Conduct internal audits upon successful completion of the Internal Auditor Qualification

Program.

• Lead backroom activities during external audits and host the frontroom activities during

internal audits.

• Develop the annual Quality Training Program based on identified organization needs,

support its deployment, and monitor its effective execution.

• Collect, analyse and communicate training feedback to trainers to support the continous

improvement of training content and delivery method.

• Oversee the preparation, implementation and completion of Annual Training Plans.

• Design and develop training materials, and provide guidance and support to other

departments in training-related activities.

• Deliver Quality and GMP-related training sessions across the organization.

• Maintain the Documentation Management System.

• Manage documents of external origin. Participate in the impact assessments, action plan

definition and follow up of the changes needed.

• Coordinate Management Review activites and maintain the associated documentation.

• Prepare general internal communications within the Quality and Regulatory Affaris (QRA)

area.

• Maintain the Change Management System, ensuring effective coordination, tracking and

timely impementation of changes and associated actions.

• Perform quality assessment of change requests, as required.

• Monitor, analyse and report the Key Performance Indicators (KPIs) related to QS-owned

processes.

• Own Non Conformities, Change Controls and CAPA directly involving QS-owned

processes.

• Manage Non Conformities, Change Controls and CAPA related to cross-functional Quality

Management System processes.

• Monitor the progress and timely closure of audit-related Non conformances and

associated CAPA.

• Participate in the design, implementation and continuous improvement of core Quality

System processes.

• Prepare and maintain Quality Management System documentation required to support

international registrations, in accordance with the registration timelines.

• Respond to customer quality questionnaries.

• Manage projects autonomously and actively contribute to the continual improvement of

the department.

• Serve as a subject matter expert (SME) of QS-owned processes during audits and

inspections, and providing guidance and support across the organization.

Networking/Key relationships

This position involves frequent interaction with all areas of the company and includes

delivering training to employees across different functions.

Minimum Knowledge & Experience required for the position:

Education:

o Required: Bachelor’s degree (Grado) in Chemistry, Biotechnology or other Sciences,

complete with competency in chemical, biological, or health-related work experience.

Degree may be substituted by relevant skills and work experience.

o Valuable: Any additional academic qualification beyond those required in the previous

section, including a Master’s degree in Quality Management.

Experience:

o Minimum of 3 years in a similar position.

Additional Skills/Knowledge:

o Software: Good knowledge of Microsoft Office and Adobe applications. Basic SAP

knowledge is desirable, together with a proven ability to adapt to new technologies.

Experience in digitalizing and optimizing processes will be considered an asset.

o Language: fluent in Spanish and/or Catalan, with advanced English communication

skills (both written and spoken).

o Standards: Extensive knowledge of regulatory requirements applicable to medical

devices and/or in vitro diagnostic medical devices, as well as Quality Management

Systems. Knowledge of additional regulations and standards will be considered an

asset. Management reserves the right to substitute relevant professional experience for

academic qualifications and/or to make exceptions to the required years of experience.

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and competencies:

• Management of decisions under pressure.

• Methodical and well-organized person.

• Ability to apply a sytematic approach and constant control, follow-up and verification of

the results.

• Time-management skills.

• Teamwork.

• Ability to collaborate, participate and coordinate actively with working groups.

• Excellent communication skills, with the ability to present information clearly and

concisely while ensuring audience understanding.

• Reflects values of Werfen in the quality of work and working relationships.

Travel requirements:

Not required.