Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. 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.
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 ensuring 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 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-conformance, Corrective and Preventive Actions (CAPA), and other quality system improvement initiatives
Organize and coordinate internal and external audits, including planning, execution and follow-up activities.
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 continuous improvement of training content and delivery methods.
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.




Prepare general internal communications within the Quality and Regulatory Affairs (QRA) area.
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.
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 questionnaires.
Manage projects autonomously and actively contribute to the continual improvement of the department.
Networking/Key relationships
This position involves frequent interaction with all areas of the company and includes delivering training to employees across different functions.
Bachelor’s degree (Grado) in Chemistry, Biotechnology or other Sciences, complete with competency in chemical, biological, or health-related work experience. o Valuable: Any additional academic qualification beyond those required in the previous section, including a Master’s degree in Quality Management.
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. o Language: fluent in Spanish and/or Catalan, with advanced English communication skills (both written and spoken).
Extensive knowledge of regulatory requirements applicable to medical devices and/or in vitro diagnostic medical devices, as well as Quality Management Systems. Ability to apply a sytematic approach and constant control, follow-up and verification of the results.
Reflects values of Werfen in the quality of work and working relationships.
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📌 Quality and Regulatory Systems Engineer (Llissá de Munt)
🏢 Werfen Immunoassay
📍 Llissá de Munt