- Conduct third party and second party audit to ensure compliance to relevant medical device quality standards and regulatory requirements.
- Ensure complete management of audits from planning, conducting audit, compliance assessment, report generation and timely submission, follow-up audits.
- Continual Improvement champion
Specific responsibilities
- Lead audit team and conduct audit for initial, surveillance and re-certification audit in a professional manner.
- Ensure that SGS Knowledge Procedures are followed for relevant product under their expertise.
- To carry out customized audit as required by Knowledge business.
- Conduct training courses under their specialty.
- Provide market information to the management team on new market trend and business opportunities.
- Staying updated with changes in medical device regulations and standards, maintain a deep understanding of the regulatory landscape.
- To carry out any additional task as required by Operation / Certification Manager
Requirements:
- Degree in Chemistry/ Biology / Microbiology/ Food Technology / Pharmaceutical / Computer/ Software Technology (IT)/ Electronic/Electrical/Mechanical Engineering
- Diverse experience as an auditor in different industries.
- A strong understanding of relevant medical device regulations and standards is essential. Knowledge of regulatory frameworks, such as the U.S. FDA's regulations (21 CFR Part 820), ISO 13485, and other international standards, is crucial.
- 5 years full time working experience in R&D and/or QA in relevant industries.
- Preferably prior auditing experience (Example: ISO 13485, ISO 9001)
- Preferably completion of recognised ISO 9001and ISO 13485 Lead Auditor Course
- Good communication, negotiation, and interpersonal skills
- Acts quickly and decisively.
- Be able to work independently with high level of initiative and resourcefulness.
- Self-motivated, meticulous
