Tus tareas: 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 range from Quality Assurance (i.e., create SOP, training plan, polyvalent matrix, measurement and calibration, non-conformance management, internal and external audits) to Quality Control (incoming inspection, verification of documents) and regulation of products (registration of product on health authority, health & Safety).
Specific Responsibilities:Document Control: Create and update SOPs for the entire BU DMT Spain following standards from headquarters and aligned with ISO 13485.Non-conformance Management: Control and manage all complaints coming from external customers, suppliers, or internal customers following specific SOPs.Calibration & Measurement: Ensure that all tools used in the BU DMT Spain are within parameters and properly calibrated. Manage documentation in accordance with retention periods.Equipment & Materials for Repair: Control and document materials sent for repair to the manufacturer, including associated costs.Training Plan: Create the yearly training plan for all staff in DMT Spain in collaboration with the Technical Service Manager Iberia.Regulatory: Register products needed for distribution in Spain and Portugal. Collect information and create technical specifications as necessary while liaising with health authorities for timely registration.Continuous Improvement: Champion Continuous Improvement in all facets of DMT Spain.Audits: Be responsible for internal and external audits.CSN Yearly Report: Consolidate information for the yearly report for the national nuclear authority for X-ray devices, including sending certificates to customers when X-ray equipment is exchanged or installed.Tu perfil: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 of MedDev market and MDD directive is a plus.Process-oriented with a problem-solver mindset.Leading by example, team player, and learning attitude.ERP knowledge as a plus.Fluent Spanish and very good English (at least B2).MS Office proficiency.¿Quiénes somos?
Dornier MedTech, based near Munich, Germany, is a medical technology company known for its innovative technologies and revolutionary therapies in urology. Dornier's success is attributed to its entrepreneurial spirit, innovation, and expertise in developing some of the highest quality urology products available today. As a co-founder of the Foundation for Urology Care, Dornier collaborates closely with physicians, healthcare providers, and research groups to ensure its products meet the highest medical and scientific quality standards.
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