Auditor - Mhs

**Tasks**
- **I.** **Responsibility and Authority**
- 1. Perform audit according to standard requirements, regulatory requirements, internal requirements, code of conduct.
- 2. Collect and analyze sufficient information to provide a recommendation for certification, with authority over the control and performance of auditing activities.
- 3. Review medical devices quality systems and technical information to the requirements of ISO 9001, ISO 13485 and other international regulatory requirements.
- 4. Should have strong exposure of ISO 13485, Medical Device Directive, Risk Management, EMC Requirements, Functional Safety.
- 5. Respond to client inquiries on all technical matters regarding certification/training products.
- 6. Report customer complaints, problems and/or system deficiencies to the Director of Healthcare and Certification Management.
- 7. Assist in the training of other auditors and lead auditors during planned audits or during other training functions.
- 8. Experience in production or quality with medical device manufacturing companies.
- **II.** **Education and Experience**
- 1. Education
- Masters degree in science.
- 2. Minimum 5 years working experience in the fields of medical device design and manufacturing.
- 3. Registered auditor; Successfully completed 5 days lead auditor course for ISO 9001:2015.

**Qualifications