Your mission
Dornier Medtech Spain is looking for a Quality & Regulatory Manager who will be responsible for managing the QA/QC & RA of products and processes to ensure that we meet industry standards in accordance with the ISO 13485 standard. The responsibilities include Quality Assurance (i.e., creating SOPs, training plans, polyvalent matrix, measurement and calibration, non-conformance management, internal and external audits), Quality Control (incoming inspection, verification of documents), and regulatory affairs of products (registration of products with health authorities, health & safety).
* Document Control: Create and update SOPs for the entire Business Unit of Dornier MedTech Spain following standards from headquarters and aligned with ISO 13485.
* Manage Non-conformance Management: Control and manage all complaints from external customers, suppliers, or internal customers following specific SOPs. Ensure timely management and proper documentation.
* CAPA Responsible.
* Calibration & Testing Equipment: Ensure that all tools used in Spain are within parameters and properly calibrated. Manage documentation in accordance with retention periods and create a yearly budget for calibration.
* Manage equipment & materials to be sent for repair: Document materials to be sent for repair to the manufacturer and maintain visibility of repair costs.
* Training Plan: Develop and create the yearly training plan for all staff in Spain. Collaborate with the Technical Service Manager Iberia to finalize training needs and ensure proper documentation.
* Health & Safety:
o Update documents to be uploaded to each hospital's platform to maintain FSE records.
o Ensure dosimeters from FSE are sent monthly for analysis and that FSE always has one available.
o Schedule medical tests for Dornier personnel.
o Document Control for Health & Safety for easy retrieval.
o Manage all PPI for each employee and maintain proper document control.
* Regulatory: Register products for distribution in Spain and Portugal. Collect information, create technical specifications, and liaise with health authorities for timely registration.
* Continuous Improvement: Champion continuous improvement in all facets of Dornier MedTech Spain.
* Audits: Responsible for internal and external audits as needed.
* CSN yearly report: Consolidate information for the yearly report to the national nuclear authority for X-ray devices.
* Training for “Tecnico Responsable Garante de Producto Sanitario“ position within 1-2 years, under compliance with the Health Ministry of Spain.
* Create specific procedures and forms for DMT Spain with Citrix platforms.
* Manage Babtec implementation in DMT Spain as required by DMT Europe.
* Communicate any changes in standards or laws that could affect the business.
* Conduct yearly Management Review following ISO 13485 standards.
Your profile
* Higher degree with specific certifications in quality (ISO13485, ISO9001).
* ISO 13485 Auditor certification desirable.
* “Postgrado en Producto Sanitario“ desirable.
* Experience in Quality Management (Assurance, Control, and Regulatory).
* Experience in Medical Devices and quality.
* Knowledge of the MedDev market and MDD directive.
* Process-oriented mindset.
* Problem solver mindset.
* Leading by example.
* Team player.
* Learning attitude.
* SharePoint database knowledge.
* ERP knowledge.
* Fluency in Spanish, Catalan, and English (spoken and written).
* Proficient in MS Office.
Why us?
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