Medical and Health Service Auditor (MHS) – Based in Rangsit, Pathumthani
PRTR Recruitment & Outsourcing
Bangkok
jobsDB ref: JTH300003002097416
Employer Ref. V-82428
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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About PRTR Recruitment & Outsourcing
Our client is a German company who provides quality assurance services, training, testing, and certifications across various types of industries (aerospace, automotive, food, transportation, health & medical care, etc.). They are now seeking candidates for the position of Auditor to be responsible for Medical and Health Services (MHS).
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