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 and continuously improving the core Quality Management System (QMS) processes, including Document Control, Change Control, Internal Audits and Training Management, ensuring compliance with all applicable regulations and standards. The role also contributes to the optimization and digitalization of quality processes, leveraging digital tools and data-driven approaches to improve efficiency and effectiveness.

The QS Engineer operates with a high degree of autonomy in the planning, coordination and execution of audits, and, upon qualification through the internal auditor qualification program, is authorized to conduct internal audits independently.

The role also serves as a subject matter expert (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-Conformances, 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.
- Coordinate and oversee the Annual Quality Training Program, ensuring alignment with organizational needs and effective implementation.
- Support the development and continuous improvement of training materials and methodologies, leveraging digital tools to enhance training effectiveness.
- Deliver Quality and GMP-related training sessions and provide guidance to other departments on training-related activities.
- 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 activities and maintain the associated documentation.
- Prepare general internal communications within the Quality and Regulatory Affairs (QRA) area.
- Maintain the Change Management System, ensuring effective coordination, tracking and timely implementation 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.
- Identify opportunities to optimize and digitalize Quality Management System processes, improving efficiency, traceability and data management.
- Develop and implement digital tools, automated workflows and reporting solutions to support Quality Systems activities, including KPI monitoring and process improvement.
- Prepare and maintain Quality Management System documentation required to support international registrations, in accordance with the registration timelines.
- Respond to customer quality questionnaires.
- 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, 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

- 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.
- Valuable: Any additional academic qualification beyond those required in the previous section, including a Master's degree in Quality Management.
- Experience: Minimum of 3 years of relevant experience in Quality Management Systems within a regulated industry, preferably Medical Devices, IVD or Pharmaceuticals. Demonstrated ability to manage QMS processes with a high degree of autonomy.

Additional Skills / Knowledge

- Software: Strong proficiency in Microsoft Office, particularly Excel, and a demonstrated ability to leverage digital tools to improve processes and workflows. Experience in process digitalization, automation, data analysis or reporting tools (e.g., Power BI) will be highly valued. Familiarity with SAP, Adobe applications and emerging technologies, including AI-based tools, will be considered an asset.
- Language: Fluent in Spanish and/or Catalan, with advanced English communication skills (both written and spoken).
- Standards: Strong knowledge of Quality Management Systems and regulatory requirements applicable to regulated industries, particularly Medical Devices, In Vitro Diagnostics (IVD) or Pharmaceuticals. Familiarity with ISO 13485, GMP and/or FDA regulatory requirements will be highly valued.

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 adecuado 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 systematic approach and constant control, follow-up and verification of 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.
- Proactive and solution-oriented mindset, with the ability to work autonomously, identify improvement opportunities and drive initiatives forward.
- Strong digital mindset, with an interest in leveraging technology, automation and innovative solutions to improve processes and operational efficiency.
- Reflects Werfen's values in the quality of work and working relationships.

TRAVEL REQUIREMENTS Not required.

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