Mhs Auditor

**Tasks**
- We are currently looking for a Medical Auditor to perform the Audits, inspections, and trainings for clients to help ensure that our client's meet the requirements of International requirements.
- This includes the following areas:

- Performing Audits in ISO 13485 / MDD, J-QMS, CMDCAS, MDSAP / Specific medical device standards
- Performing ISO 13485 / MDD / specific medical standards / and GMP inspections
- Performing in-house and public training for clients (e.g.
ISO 13485 / MDD / Specific Medical Device Standards / QSR)
- Key Responsibilities:

- Conduct audits on clients' medical device quality systems based on regulatory requirements for access into EU, Japan, and Canada
- Assist Sales by providing technical advice to existing and prospective clients and responding to inquiries relating to medical device certification
- Process clients' queries, Change Notifications, EC certificate extensions and audits effectively within acceptable time frames or when due, including quotations and contract reviews where necessary
- Take charge of pre and post-audit tasks including calculation of audit duration, quotations, audit registration, preparation of documentation and submission files and maintaining filling of paper and electronics records
- Maintain authorizations for auditing and technical reviews and corresponding objective evidence
- Ensure timely completion of audit/surveillance and submission of audit reports
- Develop and review audit methodologies for accreditation compliance
- 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 the country
- To generate, compile and prepare assessment reports and recommendations for review of certification bodies.
**Qualifications**
- ** Key Requirements**:

- Minimum 5 years of relevant experience in the medical industry, with at least 2 years in Quality Assurance work with manufacturers of medical devices with a relevant Bachelor's degree.
- Good knowledge of medical device directives, ISO 9001, and ISO 13485 standards will be an added advantage
- Global Regulatory Affairs background, including MDD/IVDD is preferred
- Clear and articulate presentation ability with excellent communication skills
- Travelling will be required within ASEAN, largely Thailand and Malaysia, occasional travel to the USA and Europe
- Willing to be relocated to ASEAN countries