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About the Role
PQMS is currently seeking an ISO 13485:2016 Lead Quality Auditor with at least 3 years of experience. This position requires a deep understanding of the ISO 13485:2016 standard and exceptional auditing skills. The successful candidate will be responsible for performing internal audits, leading audit teams, preparing audit reports, and driving continuous improvement in our quality management system.
Key Responsibilities
Perform and lead internal audits in accordance with ISO 13485:2016 standards and PQMS internal procedures.
Prepare audit plans and checklists, conduct opening and closing meetings, and compile detailed audit reports.
Identify non-conformities and opportunities for improvement, and drive corrective and preventive actions.
Provide training and guidance to other auditors and quality personnel.
Act as a liaison with external auditors during audits and inspections.
Monitor the implementation of the corrective actions to ensure effectiveness.
Participate in the management review process.
Qualifications
A minimum of 3 years of experience as a Lead Quality Auditor in a medical device or related industry.
Certified Lead Auditor for ISO 13485:2016.
Demonstrated understanding of quality management systems and quality auditing techniques.
Strong knowledge of FDA QSR, EU MDR and other global medical device regulations is desirable.
Excellent communication, leadership and interpersonal skills.
Strong attention to detail and excellent problem-solving abilities.
Bachelor's degree in a relevant field preferred.