Gdpmd Auditor
5 months ago
**Tasks**
- ** 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
**Qualifications**
- ** Key Requirements**:
- Bachelor s degree in Electrical / Biomedical Engineering, Biomedical Science, Pharmaceutical, Chemical Engineering, Chemical Science, Biotechnology or relevant Sciences
- 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, MDSAPORorGDPMD)
- Clear and articulate presentation ability with excellent communication skills
- Travelling will be required