Lead Auditor - Medical Device

Job Description

• To perform assessment, audit and gap verification of clients and applicants in accordance with SGS requirements and customer's global standard or management system.
• To conduct the audit presentations and prepare assessment reports within the timeline stipulated as per SGS and/or accreditation/oversight body requirements.
• To carry out the role as Lead Auditor effectively as per ISO 19011 (Auditing Management Systems) guidelines. He/she will be responsible in ensuring client understanding of the assessment decision and clear direction to particular items of correction, corrective action and continual improvement where appropriate.
• To recommend the issue, re-issue, suspension or withdrawal of certificates, and report recommendations in accordance with SGS policy, procedures and prescribed time frame.
• Maintain and develop own skills and knowledge both technologically and in the field of management and standards as part of continuous professional development (CPD) where appropriate.
• To perform technical review on allocated audit jobs where qualified from time to time in accordance with SGS Certification Function approval procedures.
• To establish and develop an effective quality partnership with clients with the aim of exceeding client satisfaction.
• To provide commercial referrals to Sales & Marketing department and assist in the company business budget achievement.
• To support and provide training services based on SGS Academy Annual Training Calendar as well as in-house training programs.
• At all times, comply with SGS Code of Integrity and Professional Conduct
• To perform other types of product/scheme audits on top of the primary product/scheme audit based on the business needs and qualification.
• Adherence to SGS Health, Safety and Environment (HSE) Policy by uphold a good safety behavior and exercising necessary standard and process when carry out your responsibilities at all times to ensure compliance to the HSE requirements.
• Perform any other responsibilities as assigned by your reporting manager and/or Senior Management.

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)