Quality Systems Engineer

Winid; Lliçà d'Amunt; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

Werfen seeks a QS Engineer to maintain the core QMS, manage audits, and drive continual improvement across the organization. You will act as an SME for QS processes and support CAPA and change control activities.

The role requires a bachelor’s in a science field, several years in quality, and fluency in English with Spanish or Catalan skills. SAP knowledge and regulatory awareness are valued in this on-site Barcelona area position.

Formación

• Bachelor in Chemistry/Biotechnology or related sciences required.
• Minimum 3 years in a similar quality role is expected.
• Knowledge of regulatory requirements for medical devices/IVD is essential.
• Regulatory/regulatory affairs experience is a plus.

Responsabilidades

• Organize and coordinate internal and external audits with planning and follow-up.
• Lead audit activities and support CAPA and change controls.
• Develop and deliver the Quality Training Program and materials.
• Maintain the Documentation Management System and Change Management.
• Monitor KPIs and drive continual quality improvements.
• Monitor KPIs related to QS-owned processes and support CAPA initiatives.

Conocimientos

MS Office

Adobe applications

SAP (basic)

Quality management

English (advanced)

Spanish/Catalan

Educación

Bachelor’s degree in Chemistry, Biotechnology or Sciences

Master’s in Quality Management (advantage)

Herramientas

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. 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 execution 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 activities 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 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.
• 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

• 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 in a similar position.

Additional Skills/Knowledge

• 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.
• Language: fluent in Spanish and/or Catalan, with advanced English communication skills (both written and spoken).
• 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

• Management of decisions under pressure.
• Methodical and well-organized person.
• Ability to apply a systematic 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.