Medical Device Lead Auditor | QMS & Regulatory Expert

Avetix Engineering; Massachusetts; Presencial; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

International work environment

Competitive compensation package

Professional development and training

Descripción de la vacante

Avetix Engineering seeks an experienced Medical Device Lead Auditor to join a leading Notified Body. You will plan and conduct third-party audits of manufacturers' QMS and technical documentation against ISO 13485, EU MDR/IVDR, and FDA QSR.

The role requires leading audit teams, assessing devices from Class I to III, identifying nonconformities, and reporting findings. Travel is expected as part of audits globally.

Formación

• Degree or post-graduate degree in scientific disciplines such as Biomedical Engineering, Biotechnology, Biology, Chemistry, Pharmacy, Bioengineering, or equivalent field.
• Notified Body Auditor experience required.
• Ability to travel.

Responsabilidades

• Evaluate QMS against ISO 13485 requirements to ensure conformity and continuous improvement.
• Plan, lead, and report on initial, surveillance, and recertification audits against ISO 13485, EU MDR/IVDR, and other applicable standards.
• Conduct document reviews, on-site inspections, and remote audits evaluating QMS and technical documentation for regulatory compliance.
• Assess conformity of medical devices across classes (EU I–III; US II/III), including SaMD and combination products.
• Identify nonconformities, assign classifications, and document findings clearly.
• Lead audit teams as the audit team leader (ATL), coordinating experts and auditors as required.

Conocimientos

Auditing

Regulatory compliance

Team leadership

Educación

Biomedical Engineering

Biotechnology

Biology

Chemistry

Pharmacy

Bioengineering

Descripción del empleo

Avetix Engineering seeks an experienced Medical Device Lead Auditor to join a leading Notified Body. You will plan and conduct third-party audits of manufacturers' QMS and technical documentation against ISO 13485, EU MDR/IVDR, and FDA QSR.

The role requires leading audit teams, assessing devices from Class I to III, identifying nonconformities, and reporting findings. Travel is expected as part of audits globally.