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…