We are looking for a Technical Documentation Specialist for the Oncology line who will report to the Operation Manager and collaborate with the Research and Development (R&D), Production, Quality and Regulatory Affairs (QA&RA) departments.
Functions and responsibilities:
* Manages the transfer of projects to production (design-transfer) and prepares hardware and software tools for carrying out the production process.
* Manages product/production process changes in accordance with ISO 13485, MDR 2017/745, 21 CFR part 820 and collaborates with RA for the correct documentation of the changes introduced, performing the necessary checks and validations.
* Keeps the Technical Documentation of medical devices updated in compliance with regulatory standards and manages the necessary communications with notified bodies, in collaboration with RA.
* Draws up and keeps up to date production manuals, device user manuals and labeling plans.
* Ensures the application to medical devices of the technical regulations in force on electrical safety, mechanical safety, biocompatibility, electromagnetic compatibility, usability.
* Collaborates with Research and Development for the definition of design requirements and analysis of the regulations applicable to medical devices and for the drafting of technical documentation.
* Interfaces with the design department and external suppliers to analyze the main technical problems and identify feasible solutions in the production department and/or in the development of new devices or modification of existing ones.
* Supports the production department in solving production problems with a view to continuous improvement, also through the implementation of hardware and software tools.
* Implement legislative updates in the technical documentation of the devices in collaboration with QA and RA.
* Collaborates with the Quality and AR System Manager to maintain the quality levels required in the performance of the production process.
* Supports audit activities by regulatory authorities and notified bodies.
Requirements
* Degree in engineering (biomedical/electronics) or diploma of industrial expert with specialization in industrial electronics or similar (electrical engineering / mechatronics)
* Previous experience of at least two years in the Medical Device or Pharma & Life Sciences sector
* Ability to understand technical documentation such as: standards, directives, regulations, data sheets of electronic components, wiring diagrams, instrumentation user manuals
* Knowledge of the Medical Device Regulation (MDR 2017/745), 21 CFR part 820 and applicable standards (e.g., IEC 60601-1, ISO 10993-1, ISO 14971, IEC 62366-1, IEC 62304)
* Ability to draft technical documentation according to industry standards (MDR 2017/745, IEC 60601-1, ISO 10993-1, ISO 14971, IEC 62366-1, IEC 62304)
* Basic knowledge of electronics and ability to use laboratory devices, including: oscilloscope, multimeter, gaussmeter, signal generator, tester for measurements of dielectric strength, leakage currents and insulation resistance, soldering station, benchtop power supplies
* Knowledge of the main production processes (assembly, machining, etc.)
* Good knowledge and ability to use the main office applications (Word, Excel, Powerpoint, Visio) and management programs
* Good knowledge of written and spoken English
* Predisposition to learning, flexibility, analytical and problem-solving skills
Good organizational skills and autonomous planning aimed at results.
Posizione aperta:
Ad integrazione del nostro Ufficio Tecnico siamo alla ricerca di una/un Technical Writer & Change Management Specialist che riporterà all'Operation Manager e lavorerà in stretta collaborazione con i team di Ricerca e Sviluppo (R&D), Produzione, Qualità e Regulatory Affairs (QA&RA).
Settore: Medical Devices Dispositivi Medici
Focus: Technical documentation e Change Management
Location: Carpi (MO) Lavoro in sede
Contratto: Tempo indeterminato
Orario: Full-time
Responsabilità principali:
* Gestire le Change Request di prodotto (Design Change) e di processo produttivo (es. Supplier Change Requests, Supplier Transfers), garantendo la conformità a ISO 13485, MDR 2017/745, 21 CFR part 820 e collaborando con Regulatory Affairs (RA) per la documentazione e la validazione delle modifiche.
* Aggiornare e mantenere la Documentazione Tecnica secondo gli standard normativi, interfacciandosi con enti notificati.
* Redigere ed aggiornare manuali e procedure di produzione, manuali d'uso e piani di etichettatura.
* Gestire le non conformità e le azioni correttive e preventive (CAPA), identificando ed implementando soluzioni per prevenire il ripetersi di problematiche.
* Supportare il Design Transfer ed il miglioramento continuo, predisponendo strumenti hardware e software per la produzione.
* Collaborare con fornitori esterni e R&D per la risoluzione di problematiche tecniche.
* Applicare normative tecniche relative a sicurezza elettrica e meccanica, biocompatibilità, EMC e usabilità.
* Collaborare con il responsabile Qualità e Regulatory Affairs per garantire il rispetto degli standard di qualità aziendali.
Requisiti richiesti:
* Laurea in Ingegneria (Biomedica o affini) oppure Diploma tecnico con esperienza nel settore.
* Esperienza di almeno 2 anni in ambito Medical Devices oppure Pharma & Life Sciences.
* Conoscenza del Regolamento Dispositivi Medici (MDR 2017/745), 21 CFR part 820 e degli standard normativi (IEC 60601-1, ISO 10993-1, ISO 14971, IEC 62366-1, IEC 62304).
* Esperienza nella redazione di documentazione tecnica conforme agli standard del settore.
* Conoscenza dei principali processi produttivi (assemblaggio, lavorazioni meccaniche, stampaggio di materie plastiche ecc.).
* Ottima conoscenza di Microsoft Office e strumenti gestionali.
* Buona conoscenza della lingua inglese (scritta e parlata).
* Flessibilità, capacità analitiche, problem solving e autonomia organizzativa
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