Lead Auditor - Medical Device
Hybrid · Shah Alam, Selangor, Malaysia
Job Summary
Lead Auditor responsible for performing assessments, audits and gap verifications of clients per SGS requirements and global standards; conduct audit presentations; prepare assessment reports; ensure compliance with ISO 19011; determine Certification actions (issue, re-issue, suspension or withdrawal) as appropriate; maintain ongoing CPD and develop client relationships; provide training support per SGS Academy and assist in commercial referrals; uphold SGS Code of Integrity and Professional Conduct; perform additional product/scheme audits as needed; adhere to HSE policies.
Required Qualifications
- Diploma / Degree in medical physics, biomedical engineering, biology, microbiology, biotechnology, biomedical science, chemistry, biochemistry, computer and software technology, electrical, electronic, mechanical, bioengineering, or equivalent in related field.
- Minimum of 6 years of related work experience or in similar capacity of industry.
- At least 4 years out from the total 6 years are in medical device related industries
- Preferably with auditing experience in conducting Medical Device Quality Management System audit for external parties
- Completed a Lead auditor training or recognized auditor training and proficiency course under Competent Authority (ISO 13485, ISO 9001, GDPMD, MDD, MDR, IVDD, IVDR and etc)
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