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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.
Position Overview
We are looking for a Quality Systems Engineer. She/he is responsible for ensuring the company is compliant with all applicable regulations and standards. The candidate will be autonomous regarding audit organization and capable of conducting audits, being part of the subject matter experts (SME), especially for the QS&C responsibilities. The role includes participating in the continuous improvement of the QRA area, supporting Non-conformance, Change Control, and CAPA process enhancement, and leading the document management system of the company. The candidate will own and manage the Change Control Management System.
Knowledge & Experience:
* Required: Bachelor’s degree in Chemistry, Biotechnology, or other Sciences, with competency in chemical, biological, or health-related work experience.
* Valuable: Any additional degree higher than that required, such as a master's degree in electronic document and record management systems (EDRMS) or in Quality.
* Experience: 3 years in a similar position is required.
* Tools: Fluency in Office Tools (Excel & Word) and Adobe tools; basic knowledge in SAP is valuable.
* Languages: Fluency in Spanish or Catalan; advanced knowledge of English (reading and speaking).
* Regulatory Knowledge: Deep knowledge of regulatory requirements in the area of medical devices and/or in-vitro diagnostics and quality management. Knowledge of other regulations/standards will be a plus.
Key Accountabilities:
* Accountable for organizing External and Internal Audits.
* Backroom host during external audits.
* Frontroom host during internal audits.
* Responsible for the document management system and participation in the performance-qualification of any changes on the system.
* Documents of external origin accountability. Participates in impact assessments, action plan definitions, and follow-up of changes needed in the document system.
* Change Order module responsible, ensuring GxP (good practices) and training to all workmates when needed. Accountable for the process-qualification of any changes on the module.
* Responsible for the Change Control Management System, performing quality assessment of change requests, and tracking the status of actions/changes with 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 Non-conformances arisen over the audit process.
* Participates in the design of core Quality Systems.
* Collaborates in preparing documentation related to the Quality Management System needed for international registrations, in accordance with registration timelines.
* Responsible for answering customer Quality Management System questionnaires.
* 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.
* 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 relationships.
What we offer:
* A meaningful project that will impact the quality of laboratory medicine worldwide.
* A multicultural and friendly team.
* Exciting opportunities for professional development.
* Social benefits: Canteen, nursery check, Language training...
Our Purpose:
We contribute to the advancement of patient care around the world through innovative specialized diagnostics.
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