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13 November 2019
Job ID: BK-153542
Medical and Health Service Auditor (MHS) – Based in Rangsit, Pathumthani
Job Description:
  • Performing audits in the related areas
    • Medical device quality systems, e.g. ISO 13485/MDD, 510 (K) reviews/specific medical devices standards/CMDR.
    • Any other medical regulatory requirements for access into other countries.
  • Developing and conducting in-house and public training for clients (e.g. ISO 13485/MDD/CMDR).
  • Ensuring the timely completion of audits/surveillance and the submission of audit reports.
  • Providing support in relation to technical enquiries from existing and prospective clients relating to medical device certification.
  • Proposing sales quotations for existing and prospective clients relating to medical device certification.
  • Occasional overseas travelling may be required.
  • Being responsible for audit planning, audit document reviews, on-site audits, and audit reporting.
  • Bachelor’s degree or higher in Science, Medicine, Physics, Medical Engineering, Microbiology, or equivalent to the related product or medical area.
  • Male or female, Thai nationality aged 30 or above, with a mature personality.
  • A minimum of 4 years of relevant experience in medical device manufacturing or a related industry.
  • At least 2 years in a role related to quality management / QA / internal audit / testing devices / evaluation / clinical trails or related in non-active medical device manufacturers (especially metal and plastic medical devices).
  • Knowledgeable with a global regulatory affairs background, including AIMDD/MDD/IVDD as well as medical device directives, medical device legislation, ISO 9001, ISO 13485, or other standards.
  • Must be proficient in spoken and written English.
  • Clear and articulate presentation ability with a strong service mindset and team orientation.
  • Ability to plan and organize work.
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Job Details:

PRTR Recruitment & Outsourcing
Since PRTR’s establishment in Thailand in 1990, we have been a part of a roller coaster ride called Thailand's economy. We have witnessed the highs of the property boom, the collapse of the currency, the pain Thailand suffered facing up to the stringent demands of the IMF, the demise of the American mortgage market, Thailand’s ongoing political power struggle and the recent devastating floods. We are now playing our part in Thailand's future, which will see a steady annual growth, improved health and welfare services, a decrease in poverty, an increasing domestic demand from a growing middle class and a business environment that dictates transparency and increased honesty.   We currently have 5 offices in Bangkok and 2 offices in the Eastern Seaboard of Thailand employing a total of 232 staff with a further 41 staff supporting our client partners at their locations in Thailand. Our plan is for PRTR to become Thailand’s most successful recruitment, staff outsourcing and business process outsourcing services group of companies.  

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