Lead Auditor

SGS; Shah Alam; On-site; MYR 90,000 - 150,000; Full time

Job summary

SGS in Malaysia is seeking an experienced Lead Auditor to conduct assessment, audit and gap verification of clients in line with SGS requirements and global standards. The role includes delivering audit presentations, preparing reports, and leading ISO 19011-based audits to ensure correct closure of corrective actions.

Ideal candidates bring 6+ years in related fields, with at least 4 years in medical device industries and completed Lead Auditor training.

Qualifications

• Must have lead auditor experience and auditing capability for Medical Device QMS audits.
• Minimum 6 years of related work experience, with at least 4 years in medical device industries.
• Completed lead auditor or recognized auditor training under Competent Authority (ISO 13485, ISO 9001, GDPMD, MDR/IVDR, etc.)

Responsibilities

• Perform assessment, audit and gap verification of clients and applicants per SGS requirements and customer standards.
• Conduct audit presentations and prepare assessment reports within stipulated timelines.
• Lead audit activities per ISO 19011 guidelines and drive corrective actions and continual improvement.
• Recommend issuance, re-issue, suspension or withdrawal of certificates per SGS policy and timelines.
• Maintain and develop technical knowledge through CPD and ongoing professional development.
• Perform technical reviews on allocated audit jobs as qualified.
• Establish effective client relationships to aim for high client satisfaction.
• Provide training and support to SGS Academy and internal programs.

Skills

Lead Auditor

Auditing knowledge

Education

Diploma / Degree in medical physics / biomedical engineering / biology / microbiology / biotechnology / biomedical science / chemistry / biochemistry / computer and software technology / electrical / electronic / mechanical / bioengineering or related field

Lead auditor training or recognized auditor training

Tools

Competent Authority auditing standards

Job description

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

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)