The Quality Assurance Auditor is responsible for planning, conducting, documenting, and reporting internal quality system audits to ensure compliance with applicable regulatory requirements, international standards, and company procedures. This role supports the effectiveness of the Quality Management System (QMS) through independent assessments, and participation in customer audits, certification audits, and regulatory inspections. The Quality Assurance Auditor partners with cross-functional teams to identify compliance risks, verify corrective actions, and promote continuous improvement across the organization.
Plan, conduct, and document QMS internal audits in accordance with established audit schedules and company procedures.
Evaluate compliance with applicable regulations, standards, and quality system requirements, including ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other relevant global regulatory requirements.
Evaluate the effectiveness of quality system processes and ensure they are adequately documented, implemented, and maintained.
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Audit planning – contribute to the development and execution of annual internal audit plan.
Audit fieldwork – execute audit engagements based on the approved internal audit plan (that will include follow-up audit reviews) as well as any ad hoc audit or investigation reviews (as requested by the Audit and Risk Committee or the Board from time to time); and
Audit reporting – assist on all reporting obligations to the Audit and Risk Committee, the Board or the Group CEO
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