QA / RA Specialist - Oncology

We are looking for a Specialist for the Oncology line who will 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 labelling 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

Additional requirements that are a plus if possessed:

• Basic knowledge of CAD tools and 3D printing
• Knowledge of statistical analysis and validation of test methods
• Basic knowledge of validation of production and business process support software
• Previous experience in production environments
• Experience in project management