Position Summary : The Quality & Regulatory Manager is responsible for managing the QA / QC & RA of products and processes to ensure compliance with industry standards such as ISO 13485 and MDR (2017 / 745). Responsibilities include Quality Assurance (creating SOPs, training plans, measurement and calibration, non-conformance management, audits), Quality Control (incoming inspections, document verification), and Regulatory Affairs (product registration, health & safety compliance).
Please submit your application in English.
Responsibilities
* Document Control : Create and update SOPs for DMT Spain, aligned with ISO 13485 and MDR standards.
* Complaint & Non-conformance Management : Control and manage complaints from customers, suppliers, or internal sources, ensuring timely handling and proper documentation.
* CAPA : Responsible for Corrective and Preventive Actions.
* Calibration & Testing Equipment : Ensure tools are within parameters, properly calibrated, documented, and maintained. Develop budgets and suggest new tools.
* Equipment & Material Repairs : Manage repair processes and associated costs.
* Training Plan : Develop and oversee annual training for staff, collaborating with the Technical Service Manager Iberia.
* Health & Safety : Maintain updated documentation, ensure field service engineers' dosimeters are sent monthly, schedule staff medical tests, and manage related documentation.
* Regulatory : Register products in Spain and Portugal, gather technical specifications, and liaise with authorities for timely registration.
* Continuous Improvement : Lead initiatives for ongoing improvement across DMT Spain.
* Audits : Serve as responsible person for internal and external audits.
* CSN Yearly Report : Compile information for the annual report to the Spanish nuclear authority for X-ray devices and provide certificates upon equipment installation or exchange.
* Training for Regulatory Position : Train to assume the role of “Tecnico Responsable Garante de Producto Sanitario” within 1-2 years, per Spanish regulations.
* Procedures & Forms : Create specific procedures and forms on the Cytrix platform for DMT Spain.
* Babtec Implementation : Manage the deployment of Babtec software in DMT Spain.
* Communication : Notify staff of changes in standards or laws affecting the business.
* Management Review : Provide information for management review in accordance with ISO 13485.
Your profile
* Higher degree with certifications in quality standards (ISO 13485, ISO 9001).
* ISO 13485 Auditor certification is desirable.
* Experience in Quality Management, Assurance, Control, and Regulatory affairs.
* Experience with Medical Devices and quality systems.
* Knowledge of the MedDev market and MDR (2017 / 745).
* Process-oriented, leadership by example, team player.
* ERP knowledge, proficiency in MS Office.
* Fluent in Spanish, Catalan, and English (spoken and written).
About us
Dornier MedTech, headquartered near Munich, Germany, is a pioneer in urology medical devices and a subsidiary of Advanced MedTech. We are committed to innovation, patient safety, and product efficacy, setting standards in digital urology and supporting communities worldwide.
#J-18808-Ljbffr