Candidates should possess strong skills in Auditing and Financial Audits to conduct detailed reviews and ensure compliance with professional standards.
Candidates should possess solid knowledge of Finance and Financial Statements to analyze client accounts and support accurate reporting.
Candidates should possess robust Analytical Skills to interpret financial data, identify issues, and propose practical solutions.
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Lead and conduct 3rd-party audits at medical device manufacturers in Malaysia and the wider ASEAN region
Assess quality management systems and technical documentation against applicable standards and regulations (e.g. ISO 13485, MDR, IVDR, MDSAP, local regulations where applicable)
Prepare high-quality documentation timely follow-up on client requests.
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Perform QMS audit to vendors within scope of medical device, drug product, cosmetic product and lab, write audit report, and follow-up supplier CAPA.
Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820 or 21CFR210&211, and support vendor for FDA audit, act as consultant to help vendor establish a better QMS with professional suggestions.
Monitor vendors’ quality management system with proper visiting in key vendor FDA projects, identify their QMS problems under regular review.
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