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, we are looking for a Quality Systems Engineer. She/he is responsible for ensuring the company is compliant with all applicable regulations and standards.
Is autonomous regarding audit organization and capable of conducting audits, being part of the subject matter experts (SME), especially for the QSC responsibilities.
Participates in the continuous improvement of the QRA area, being supportive in the Non-conformance, Change Control, and CAPA process enhancement and leads the documental management system of the company.
Owns and manages the Change Control Management System.
Knowledge Experience:
1. Required: Bachelor's degree in Chemistry, Biotechnology, or other Sciences with competency in chemical, biological, or health-related work experience.
2. Valuable: Any additional degree higher than that required, such as a master's degree in electronic document and record management system (EDRMS) and/or a master's degree in Quality.
3. Experience is required: 3 years in a similar position.
4. Fluency in Office Tools (Excel, Word) and Adobe tools, and valuable basic knowledge in SAP.
5. Fluency in Spanish or Catalan.
6. Advanced knowledge of English (reading and speaking).
7. Deep knowledge of regulatory requirements in the area of medical devices and/or in-vitro diagnostics and quality management.
8. Any other regulation/standard knowledge will be a plus.
Key Accountabilities:
1. Accountable for organizing External and Internal Audits.
2. Backroom host during external audits.
3. Frontroom host during internal audits.
4. Responsible for the documental management system and participation in the performance qualification of any changes on the system.
5. Documents of external origin accountability.
6. Participates in the impact assessments, action plan definitions, and follow-up of the changes needed in the documental system.
7. Change Order module responsible, ensuring GxP (good practices) and training to all workmates when needed.
8. Also accountable for the process qualification of any changes on the module.
9. 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.
10. Controls and reports her/his own KPIs of the department.
11. Leads/Owns Non-Conformities, Change Controls, and CAPA of the QS department.
12. Responsible for the follow-up of the Non-conformances arisen over the audit process.
13. Participates in the design of core Quality Systems.
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