Medical and Health Services
1 week ago
**Tasks**
- **
Key Responsibilities**:
- Conduct audits on medical device quality systems based on ISO 9001, ISO 13485, MDD 93/42/EEC, MDSAP and other regulatory requirements for access into EU, Japan, Canada and US
- Ensure timely submission of audit reports
- Address technical enquiries and propose quotations for medical device certification related services
- Travel overseas as required to interface with clients outside of Indonesia
- Participate in mandatory training courses as part of the medical device auditor authorization process
- Perform business and service support work as assigned
**Qualifications**
- **
Key Requirements**:
- Bachelor or Postgraduate degree in Electrical and Electronics Engineering, Biomedical Engineering or related discipline
- At least 3 years of relevant experience in medical device manufacturing Quality Assurance and/or process validation roles
- A proactive, enthusiastic, and resourceful team player with a “can-do” attitude
- Conversant in Bahasa and English, both written and spoken
- Ability to work independently to assume challenging projects within tight timelines
- Training bond applies for the completion of the auditor authorization process
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