Position

The successful candidate will join the Quality Assurance & Regulatory Affairs Department and will have the opportunity to support departmental activities across different product types and risk classes. The role also requires proactive collaboration with all company departments.

The main activities are:

• Prepare, in collaboration with suppliers, technical documentation and related files for the registration of supplied medical devices (arthroscopy devices), and manage communications with the Notified Body (Class IIa and IIb devices).
• Ensure the Quality Management System is updated to include the management of these medical devices.
• Ensure the execution of periodic controls required for sterilization processes.
• Ensure the proper management of supplier qualification activities.
• Review acceptance documentation for raw materials and semi-finished products.
• Manage non-conformities and CAPA activities.
• Participate in Notified Body, customer, and internal audits.
• Review batch records and approve the release of finished products and semi-finished product batches within the company’s IT systems, ensuring compliance with established timelines. Prepare and verify the accuracy of the related release documentation.
• Review sterilization process documentation, including parametric and documentary release.
• Support complaint handling and incident reporting activities.

Education and Experience

• Bachelor’s or Master’s degree in Chemical, Mechanical, or Biomedical Engineering, or another scientific discipline.
• Excellent written and spoken English.
• At least 3 years of experience in a Quality Assurance role within the medical device industry.

Skills and competencies:

• Knowledge of the main regulations and standards applicable to the medical device industry, particularly:
  • ISO 13485 and ISO 14971
  • Medical Devices Directive 93/42/EEC
  • EU Medical Device Regulation (MDR) 2017/745
• Proficiency in Microsoft Office.
• Knowledge of technical documentation management.
• Understanding of mechanical drawing principles.
• Knowledge of project and planning management principles.
• Proactive attitude with excellent organizational skills and the ability to work both independently and as part of a team.

Compensation
Salary will be commensurate with the candidate’s experience (Annual Gross Salary: €28,000–€35,000).

Work Location

Merate (LC), Full Time Monday-Friday.

Who is Permedica S.p.A.

Permedica Spa is a leading Italian company in the orthopedic sector that develops, manufactures and markets joint prostheses and custom made solutions for the most complex cases, oncological orthopedics and amputees. From the main headquarters in Merate (LC), cutting-edge products are manufactured and distributed worldwide, thanks to subsidiaries and collaborators present on five continents.