QA & Compliance Leader - Medical Devices (ISO 13485)

Jefferson Wells , on behalf of a leading company operating in the pharmaceutical and medical device sector, is looking for a Quality Assurance Manager to be based in Rome, for an initial fixed-term contract. The selected candidate will play a key role in ensuring compliance with applicable regulations and international standards, as well as in driving continuous improvement of quality and information security systems across the organization.

Key Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485 and applicable medical device regulations (e.g., MDR, FDA), ISO 27001, ISO 9001.
• Oversee document control, design control, risk management, supplier quality, CAPA, nonconformance management, and internal audits.
• Ensure effective execution of product lifecycle processes, including verification, validation, and traceability.
• Ensure policies and controls related to data integrity, confidentiality, and availability are in place and compliant.
• Participate in risk assessments, incident management, and perform internal audits.
• Coordinate internal and external audits.
• Prepare for and support internal, customer, and regulatory audits, and manage follow-up actions.
• Maintain readiness for inspections and certification audits (e.g., Notified Bodies, regulatory authorities).
• Develop and deliver training programs on quality and information security procedures.
• Ensuring documentation (SOPs, work instructions, records) is accurate, current, and audit-ready.
• Work closely with departments such as R&D, production, IT, regulatory affairs, and customer service to ensure quality and security requirements are understood and met.

Annuncio valido fino a: 31-May-2026