1. Plan and conduct audits in compliance with ISO 13485, EU MDR, and MDSAP standards.
2. Review and evaluate technical files and documentation for medical devices.
3. Collaborate with audit teams to ensure quality, compliance, and client satisfaction.
4. Support certification decisions and regulatory reviews as per DNV and accreditation guidelines.
Role Responsibilities:
1. Execute audits independently and manage auditing teams when needed.
2. Maintain audit documentation and timely delivery of reports.
3. Ensure adherence to global regulatory and accreditation standards.
4. Engage with clients and internal stakeholders to support quality assurance.