Quality & Regulatory Manager Spain (m/w/d)

Dornier Medtech Spain is looking for a Quality & Regulatory Manager which will be responsible of managing the QA/QC & RA of products and processes to ensure that we meet industry standards in accordance with the ISO 13485 standard. The responsability goes from Quality Assurance (i.e, create SOP, training plan, polivalent matrix, measurement and calibration, non conformance management, internal and external audits...) Quality control (incoming inspection, verification of documents...) and regulatory affairs of products (resgistration of product on health authority, health & Safety...) . 

• Document Control: Create and update SOPs for the entirely Business Unit of Dornier MedTech Spain following standards coming from headquarters and aligned with ISO 13485.
• Manage the complains of Non-conformance Management: Control and manage all complains coming from external customers, suppliers or internal customers following specific SOPs. Make sure that all of them are managed in a timely manner and properly documented
• CAPA Responsible 
• Calibration & Testing Equipment: Assure that all tools used in the Spain are within parameters and properly calibrated. Make sure that all documentation is managed properly and in accordance with retention periods. Create a yearly budget for that yearly
• Manage equipment & materials to be send for repair: Manage and document the material to be sent for repair to the manufacturer. Also have a clear visibility of costs associated with repair materials 
• Training Plan: Develop and create the yearly training plan for all members of the staff in Spain. Together with the Technical Service Manager Iberia take the final decision on what is needed for everyone. Make sure the training plan is followed and documented properly. 
• Health & Safety: 
  • Update all documents to be upload in the platform of each hospital to maintain all records of the FSE updated. 
  • Make sure that all dosimeter from FSE are sent in a monthly basis for analysis and that the FSE has always one available. 
  • Schedule Medical test for the Dornier personnel.
  • Document Control for Health & safety in a way which all is retrieved easily. 
  • Manage all PPI to be done to each employer and take proper document control.
• Regulatory: Registration of the products needed to be distributed in Spain and Portugal. Collect all information, create any technical specification and be in touch with the health authorities for proper registration in a timely manner. 
• Continuous improvement: Be the champion on Continuous improvement in all facets of Dornier MedTech Spain. 
• Audits: Be the responsible person in Spain for internal and external audits as needed.  
• CSN yearly report: Make and consolidate all information to do the yearly report for the national nuclear authority for X-ray devices. 
• To be trained to take on the “Tecnico Responsable Garante de Producto Sanitario“ position, within 1-2 years, under compliance of Health Ministry of Spain.
• Be responsible for the creation of specific procedures and forms for DMT Spain with Cytrix plattforms.
• Managing Babtec implementation in DMT Spain, as DMT Europe demand 
• Communicate to everyone in DMT Spain any change on standards or law that could affect the business 
• Yearly Management Review following ISO 13485 standards  

• Higher degree with specific certifications on quality (ISO13485, ISO9001)
• Certificate of ISO 13485 Auditor desirable 
• “Postgrado en Producto Sanitario“ desirable
• Experience in Quality Management (Assurance, Control and regulatory)
• Experience in Medical Devices and quality 
• Knowledge on MedDev market and MDD directive
• Be Process oriented. 
• Problem solver mindset
• Leading by example
• Team player
• Learning Actitude 
• SharePoint database Knowledge
• ERP knowledge
• Spanish, Catalan and English spoken and written 
• MS Office

Dornier MedTech is a medical device company headquartered near Munich, Germany, and a wholly owned subsidiary of Advanced MedTech. As a pioneer in the field of urology, Dornier is one of the most trusted names in the industry.

With the introduction of several breakthrough technologies and revolutionary therapies in recent years, we continue to drive medical performance and pioneer innovation in urology. As the world's first MDR-certified integrated urology company and one of the founders of the Urology Care Foundation (formerly known as the American Foundation for Urologic Diseases), we pride ourselves on holding ourselves to the highest standards of patient safety and product efficacy.

Today, we are setting new standards in digital urology to provide holistic care to patients seeking treatment and support the community on their road to recovery, both online and on-site.

Trusted by thousands of physicians and patients, Dornier is committed to supporting our urological communities worldwide.