Your mission
Position Summary: The Quality & Regulatory Manager is responsible for managing the QA/QC & RA of products and processes to ensure that they meet industry standards in accordance with ISO 13485 standard and MDR (2017/745). The responsibilities range 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...) to Regulatory Affairs of products (registration of product on health authority, health & Safety...).
Please send your application in English language.
Responsibilities
Please send your application in English language.
Responsibilities
- Document Control: Create and update SOPs for the business unit of DMT Spain following standards from headquarters and aligned with ISO 13485 and MDR (2017/74
- Manage the complaints of non-conformance Management: Control and manage all complaints coming from external customers, suppliers or internal customers. Make sure that all of them are managed in a timely manner and properly document
- CAPA responsible
- Calibration & Testing Equipment: Assure that all tools used in DMT 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 and make suggestions for new tools needed
- Manage equipment & materials to be sent for repair: Manage and document the material to be sent for repair to the manufacturer. Also have a clear understanding of costs associated with repair material
- Training Plan: Develop and create the yearly training plan for the staff in DMT 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 uploaded on the platform of each hospital to maintain all records updated. Make sure that all dosimeter from the field service engineers are sent in a monthly basis for analysis and ensure availability. Schedule Medical tests for the staff. Document Control for Health & safety. Manage all PPI 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 If needed 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 DMT Spain
- Audits: Be the responsible person in DMT Spain for internal and external audits as needed
- CSN yearly report: Draw 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
- Validations per demand
- To be trained to assume the “Tecnico Responsable Garante de Producto Sanitario“ position, within 1-2 years, in compliance with regulations of the Health Ministry of Spain.
- Be responsible for the creation of specific procedures and forms for DMT Spain on the Cytrix platform.
- Managing Babtec implementation in DMT Spain.
- Communicate to everyone in DMT Spain any change on standard or law that could affect the business
- Provide Information for Management Review following ISO 13485 standard