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26 November 2018
Job ID: PT-133
AUDITOR (MEDICAL & HEALTH SERVICES)

Key Responsibilities:

  • Conduct audits / tests / training on medical devices related quality systems and products to the following requirements:
    • Medical devices auditing and testing e.g. ISO 13485 / MDD, 510(k) reviews
    • Performing audits on ISO 13485 / MDD / specific medical devices standards / CMDR
    • Performing in-house and public training for clients (e.g. ISO 13485 / MDD / CMDR
    • other regulatory requirements for access into EU, Japan, Canada and USA
  • Ensure timely completion of audit/surveillance and submission of audit reports
  • Support technical enquiries from existing and prospective clients relating to medical device certification
  • National or overseas travelling is required

 Key Requirements:

  • Thai Citizen preferred
  • Minimum a Bachelor degree in a technical or science related discipline
  • Minimum 4 years of relevant experience in the medical device, healthcare or other related industries which includes either product testing or quality management related activities
  • Knowledge in any of the following will be advantageous:
    • Medical device directives, medical device legislation, ISO 9001, ISO 13485 or other standards
    • Global Regulatory Affairs background, including AIMDD / MDD / IVDD
  • Clear and articulate presentation ability with good command of spoken and written English
  • Ability to plan and organize work
  • Holds a valid Passport and willing to travel

5-day workweek, attractive remuneration and benefits will be offered to the right persons.

Interested applicants are invited to apply in person or send application (English only) with full resume indicating qualifications and experience, transcript, expected salary and recent photo to:

TUV SUD (Thailand) Limited
111 Moo 9, Paholyothin Road,
T. Klong Nueng, A. KLong Luang
Pathumthani 12120
Tel. 02-564-8041 # 119
Visit Website: www.tuv-sud.co.th


Job Details:

Benefits:
  • Five-day work week

TUV SUD (Thailand) Limited
TÜV SÜD – A global leader in the field of testing, inspection, management system certification and product certification renowned for quality, integrity and technical excellence. Established more than 150 years ago in Germany, TÜV SÜD is a leading global provider of technical services. We support our clients in a vast range of industrial sectors with testing, inspection, auditing, training and expert knowledge services that aid to improve quality, safety and reliability while ensuring environmental protection and cost effectiveness. More than 22,000 highly skilled employees across 800 offices around the globe pool their multidisciplinary expertise to partner clients in their business processes, enhancing their competitive strength and delivering tangible economic added value. TÜV SÜD Thailand offers a complete range of testing, certification, inspection and knowledge services, with testing laboratories and facilities that are accredited according to the requirements of ISO/IEC Guide 25 (ISO/IEC 17025). TÜV SÜD Thailand is also accredited to provide third-party certification services by JAS-ANZ, Australia and New Zealand’s accreditation body, Deutsche Akkreditierungs Rat (DAR), German accreditation body for organizations operating in unregulated areas and Zentralstelle der Länder für Gesundheitsschutz (ZLG), a German accreditation body for medicinal products and medical devices. What Differentiate Us TÜV SÜD is a global brand synonymous with quality, safety and world-class expertise. Building on our heritage of German precision and engineering excellence, our best-in-category experts deliver premium services worldwide to our clients. Our people share a commitment to enhancing safety and adding tangible value to businesses, consumers and the environment. Join us if you identify yourself as: Independent and impartial Taking decisions that matter Working for a greater purpose Meeting new trends with clever solutions    www.tuv-sud.co.th