About this role

Manage client portfolio, deadlines, and audit planning;
Conduct external audits in-person and/or remotely;
Prepare detailed reports with evidence of compliance and opportunities for improvement;
Follow up on corrective action plans resulting from nonconformities identified during audits;
Actively participate in trainings, mentorships, and workshops organized by QMS Certification.

Bachelor's degree or higher in quality-related fields, engineering, health, medical devices, or technology;
Knowledge of ISO 13485:2016;
Knowledge of auditing practices in accordance with ISO 19011;
Lead Auditor certification for ISO 9001 and/or ISO 13485;
Proven experience in quality management, medical devices, auditing, industry, healthcare, research, or consulting;
Knowledge of regulatory requirements applicable to medical devices (e.g., ANVISA, FDA);
Knowledge of risk management for medical devices (e.g., ISO 14971);
Ability to prepare technical audit reports;
Availability for on-site and remote audits;
Intermediate proficiency with Microsoft Office;
Clear and assertive verbal and written communication skills;
Professional ethics and impartiality.

Third-Party Auditor – Medical Devices, ISO 13485

Key skills