QUALITY SYSTEMS ENGINEER

We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Autoimmunity and Transfusion and transplant. In addition, we research, develop, and manufacture customized assays and biomaterials through our OEM business line.As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostics products.In Werfen, we are, looking for a Quality Quality Systems Engineer, She/he is responsible to ensure the company is compliance with all applicable regulations and standards. Is autonomous regarding audit organization and capable to conduct audits, being part of the subject matter experts (SME) as well, specially for the QS&C responsibilities . Participates in the continuous improvement of the QRA area, being supportive in the Non-conformance, Change Control and CAPA process enhancement and leaders the documental management system of the company. Owns and manages the Change Control Management System.Knowledge & Experience:• Required: Bachelor’s degree (grado) in Chemistry, Biotechnology or other Sciences complete with competency in chemical, biological, or health-related work experience.• Valuable: Any additional degree higher than that required in the previous section, like master degree in electronic documental and record management system (EDRMS), and/or in Master degree in Quality.• Experience is required, 3 years in a similar position.• Fluency in Office Tools (Excel & Word) and Adobe tools, and valuable basic knowledge in SAP• Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking)• Deep knowledge of regulatory requirements in the area of medical devices and/or in-vitro diagnostics and quality management. Any other regulation/ standard knowledge will be a plus.Key Accountabilities• Accountable for organizing External and Internal Audits.• Backroom host while external audits.• Frontroom host while internal audits.• Responsible for the documental management system, and participation in the performance-qualification of any changes on the system.• Documents of external origin accountability. Participates in the impact assessments, action plan definitions and follow up of the changes needed in the documental system.• Change Order module responsible, ensuring GxP (good practices) and training to all workmates when needed. Also accountable for the process-qualification of any changes on the module.• Responsible for the Change Control Management System, performs the quality assessment of the change requests, and tracks the status of actions /changes with the involved departments/areas.• Controls and reports her/his own KPIs of the department.• Leads/Owns Non Conformities, Change Controls and CAPA of the QS department.• Responsible for the follow up of the Non conformances arisen over the audit process.• Participates in the design of core Quality Systems.• Collaborates preparing the documentation related with the Quality Management System needed for international registrations, in accordance with the registration timelines.• Responsible for answering the customer Quality Management System questionnaries.• Autonomous person to carry out project management, participating in the continuous improvement of the department.Skills & Capabilities:• Management of decisions under pressure.• Methodical and well-organized person.• Teamwork• Time management skills• Ability to express information clearly and concisely to the staff, ensuring their understanding.• Ability to apply a systematic approach and constant control, follow-up and verification of the results.• Ability to collaborate, participate and coordinate actively with working groups.• Reflects values of Werfen in the quality of work and working relationship.What we offer:• A meaningful project that will impact the quality of laboratory medicine worldwide• Multicultural and friendly team• Exciting opportunities for professional development.• Ongoing training• Social benefits: Canteen, nursery check, Language training...• Retirement PlanOur Purpose: We contribute to the advancement of patient care around the world through innovative specialized diagnosticsJOIN US!