Medical Device Auditor

2 weeks ago


Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time
Your career opportunities at the TÜV SÜD Group

Conduct audits in accordance to the relevant regulations, quality standards, policies, and other required criteria on the part of the auditor.

Ensure timely completion of audit/surveillance and submission of audit report.

Develop and review audit methodologies for accreditation compliance.

Develop and conduct related training courses.

Provide support for other departments on day-to-day planning, marketing, operations, and new product development.

Undergo relevant training, qualification, or certification process to be qualified to provide further services.

Implement and uphold medical device laws and regulations of Malaysia.

Educate and train manufacturers on the importance of complying with the Malaysian Medical device laws and regulations.

Generate, compile, and prepare assessment reports and recommendations for review of certification bodies.

Plan, conduct, and follow up on audits as assigned by the Head of the MHS Department (i.e., MHS Manager) to follow up on items assigned by Medical Device Certification bodies.

Key Requirements:

Bachelor's degree in Electrical / Biomedical Engineering, Biomedical Science, Pharmaceutical, Chemical Engineering, Chemical Science, Biotechnology, or relevant Sciences.

Minimum 4 years of relevant experience in the medical device manufacturing industry.

At least 2 years' experience in Quality Management Systems (ISO 13485, MDD / MDR, MDSAP, or GDPMD).

Clear and articulate presentation ability with excellent communication skills.

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