Quality Technician (m/f/d)

Description

Job Summary: The Quality Technician will support quality assurance management, quality control, and regulatory affairs, as well as provide cross-functional support to the Technical Department. Key Highlights: 1. Comprehensive management of quality assurance and regulatory affairs. 2. Cross-functional support to the Technical Department and occupational risk management. 3. Opportunity to work with ISO 9001 and ISO 13485 quality management systems. #### **Your Responsibilities** Position summary and objective: The Quality Technician will support the Head of Technical Services in managing quality assurance, primarily: documentation update and maintenance, measurement and calibration, nonconformance management, corrective and preventive actions (CAPAs); quality control, primarily: incoming inspection and documentation verification; and regulatory affairs: product registration maintenance, submission of regulatory documentation, and annual reporting to the Nuclear Safety Council. Additionally, the role will provide cross-functional support to the Technical Department, assisting with administrative, logistical, and occupational risk tasks. Main responsibilities: a) Document control * Creation and review of Standard Operating Procedures (SOPs) for the DMT\-Spain business unit, aligned with DMT’s global requirements. b) Complaints and RMAs * Management of complaints and RMAs: preparation of forms, analysis of nonconformities / RMAs, and control of nonconforming products. * CAPA management. c) Measurement and testing equipment * Management of measurement and testing equipment and tools used at DMT\-Spain: coordinate calibrations with external laboratories and DMT technicians to ensure technicians always have appropriate, calibrated, and documented equipment for their work. d) Quality control * Quality control of incoming products, both imported and distributed. * Manage product release with the Technical Manager (external) e) Environmental monitoring * Monitor and document warehouse conditions (thermometers and hygrometers) to ensure appropriate storage of medical devices f) Regulation * Management of regulatory documentation related to suppliers and distributors: certifications and technical data. * Coordination with the external Technical Manager to maintain product records. g) CSN * Preparation of the annual report for the Nuclear Safety Council regarding X-ray devices. * Radiation dosimeter management in collaboration with the technical team and external laboratories. h) Other responsibilities * Occupational risk management, personal protective equipment management. * Occasional support to the logistics department. #### **Your Profile** a.) Academic background * University degree or Higher Vocational Training qualification in life sciences. b.) Experience * Quality management systems (ISO 9001, preferably ISO 13485\) * Desirable experience in the medical device industry. c.) Aptitude * Problem-solving mindset * Teamwork * Learning attitude * Proactive d.) Operational skills (skills) * MS Office. * Spanish and Catalan, spoken and written. * Fluent English, spoken and written. #### **About Us** Dornier MedTech is a medical device company headquartered near Munich, Germany, and a wholly owned subsidiary of Advanced MedTech. As a pioneer in urology, Dornier is one of the most trusted names in the industry.