Date Posted:

Salary:

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)

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

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