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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Support and assist Audit Manager and Partner in the planning, execution and delivery of assurance engagements
Documenting the execution of specific audit procedures as defined by the engagement objectives, audit client’s engagement history, and planned audit approach
To handle more complex statutory auditing and accounting assignments independently.
Participate in client assignments from planning to completion, including executing audit procedures with minimal supervision and ensuring audit work papers are properly documented to support audit conclusions.
Guide and assist junior team members in preparing audit schedules and executing audit procedures.
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An Audit Senior will perform and supervise aspects of the engagements for all the clients, responsible for conducting audits related, risk assessments and training of Auditors and to be able to formulate audit approaches to areas assigned to review as well as potential solutions for remediation.
Main Tasks:– Audit Planning– Audit Execution– Audit Fieldwork– Audit Reporting