Quality Assurance Manager (Medical Device) - fixed term contract

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

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