Global Medical Device Lead Auditor – ISO 13485 & MDR

Avetix Engineering; Texas; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Professional development

International exposure

Job summary

Avetix Engineering is seeking an experienced Medical Device Lead Auditor to join our Notified Body team. You will evaluate safety, performance, and regulatory compliance of medical devices from manufacturers worldwide, planning and conducting third-party audits of QMS and technical documentation to ISO 13485, EU MDR/IVDR, and FDA QSR.

Responsibilities include leading audits (initial, surveillance, recertification), document reviews, on-site and remote assessments, and coordinating experts as ATL

Qualifications

• Degree or post-graduate degree in scientific disciplines such as Biomedical Engineering, Biotechnology, Biology, Chemistry, Pharmacy, Bioengineering, or equivalent field.
• Previous Notified Body Auditor Experience.
• Ability to travel.
• Familiarity with EU MDR 2017/745 and IVDR 2017/746 requirements, including Annex IX, X, and XI conformity routes.

Responsibilities

• 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 standards.
• Conduct document reviews, on-site inspections, and remote audits for regulatory compliance.
• Assess conformity of devices across classes (EU/US) including SaMD and combination products.
• Identify nonconformities, classify (major/minor/observation), and document findings clearly.
• Lead audit teams as ATL, coordinating technical experts and other auditors as required.

Skills

Notified Body Auditor Experience

Travel Availability

EU MDR/IVDR knowledge

Education

Degree or post-graduate degree in biomedical-related field

Job description

Avetix Engineering is seeking an experienced Medical Device Lead Auditor to join our Notified Body team. You will evaluate safety, performance, and regulatory compliance of medical devices from manufacturers worldwide, planning and conducting third-party audits of QMS and technical documentation to ISO 13485, EU MDR/IVDR, and FDA QSR.

Responsibilities include leading audits (initial, surveillance, recertification), document reviews, on-site and remote assessments, and coordinating experts as ATL