Técnico de Calidad y Normativa/ Quality & Regulatory Technician (m/w/d)

The Quality & Regulatory Technician manages the QA/QC & RA of products and processes to ensure we meet industry standards in accordance with ISO 13485 standard. 
The responsibilities goes from Quality Assurance (i.e, create SOP, training plan, polyvalent matrix, measurement and calibration, non-conformance management, internal and external audits...) Quality control (incoming inspection, verification of documents...) to regulation of products (registration of product on health authority, health & Safety...) . 
 
2. Specific Responsibilities

1. Document Control: Create and update SOPs for the entire BU DMT Spain following standards coming from headquarters and aligned with ISO 13485.
2. Non-conformance Management:Control and manage all complain coming from external customers, suppliers or internal customers following specific SOPs. 
   1. Calibration & Measurement: Assure that all tools used in the BU DMT Spain are within parameters and properly calibrated. Make sure that all documentation is managed properly and in accordance with retention periods. 
   2. Equipment & materials to be send for repair: Control and document the material to be sent for repair to the manufacturer. Also have a clear point of cost associated with repair material. 
   3. Training Plan: Create the yearly training plan for all member of the staff in DMT Spain. Together with the Technical Service Manager Iberia take the final decision on what is needed. 
   4. Regulatory: Registration of the products needed to be distributed in Spain and Portugal. Collect all information, if needed create any technical specification and be in touch with the health authorities for proper registration in a timely manner
   5. Continuous improvement: Be the champion on Continuous improvement in all facets of DMT Spain. 
   6. Audits: Be the responsible in DMT Spain for internal and external audits  
   7. CSN yearly report: ( with Service Dept. Assistance) Make and consolidate all information to do the yearly report for the national nuclear authority for X-ray devices. Also send to the customer the certificate every time a X-ray equipment is exchanged or installed, following the authority. 

• Higher degree,  with specific certifications on quality (ISO13485, ISO9001) as  a plus
• Certificate of ISO 13485 Auditor desirable
• Experience in Quality Management (Assurance, Control and regulatory)
• Experience in Medical Devices and quality, or similar.
• Knowledge on MedDev market and MDD directive is a plus
• Process oriented. 
• Problem solver mindset
• Leading by example
• Team player
• Learning Attitude
• ERP knowledge as a plus
• fluent Spanish and very good English (at least B2)
• MS Office

Dornier MedTech, con sede cerca de Munich, Alemania, es una empresa de tecnología médica conocida por sus tecnologías innovadoras y terapias revolucionarias en urología. Dornier debe su éxito a su arraigado espíritu empresarial, innovación y experiencia en el desarrollo de algunos de los productos de urología de mayor calidad que existen hoy en día en el mercado.