Medical Device Auditor
TÜV SÜD
Date: 5 days ago
City: Shah Alam
Contract type: Full time
Tasks/Aufgaben
Key Responsibilities:
Key Requirements:
Key Responsibilities:
- 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.
- To implement and uphold medical device laws and regulations of Malaysia
- To educate and train manufacturers at large on the importance of complying with the Malaysian Medical device laws and regulations
- To generate, compile and prepare assessment reports and recommendations for review of certification bodies.
- To 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
- Must have minimum 4 years of relevant experience in medical device manufacturing industry
- Have 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
- Travelling will be required
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