Quality Assurance Specialist

About the role

We are a global developer and manufacturer of interventional medical devices seeking a full‑time Quality Assurance Specialist for our Italian headquarters. Reporting to the QA Manager, you will help maintain and improve our Quality Management System to ensure compliance with ISO 13485 and EU MDR 2017/745.

Key responsibilities

• Support the creation, revision, implementation, and release of QMS procedures.
• Participate in internal and external audits and manage audit documentation.
• Oversee product change control and CAPA processes.
• Prepare validation protocols and reports for cleanroom qualification and other validation activities.
• Assist the QA Manager with management review preparation and other system activities.
• Conduct trend analyses with the Clinical team to support complaint handling.
• Maintain usability documentation and contribute to continuous QMS improvement.

Required profile

• Bachelor’s degree or equivalent in a scientific or technical field.
• Minimum 3 years of QA experience in a regulated environment, preferably medical devices.
• Strong knowledge of ISO 13485 and EU MDR 2017/745.
• Experience with internal and/or external audits.
• Fluent written and spoken English.
• Auditor certification is a strong advantage.

Required skills

• ISO 13485
• EU MDR 2017/745
• CAPA management
• Validation protocol development
• Cleanroom qualification
• Internal auditing
• External auditing

What we offer

• Location: CID S.p.A., Via Crescentino SNC, 13040 Saluggia (VC), Italy.
• Salary level D1–C2 of the "Industria‑Chimica" CCNL, RAL €34,000 – €36,000.
• Equal opportunity employer, open to all genders, ages, and nationalities.