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ISO 13485 Auditor

Published : 26/08/2022
Location : Hong Kong
Career Level : Middle
Dept : Auditing
Type of cooperation : Employed or Freelance
Reference number : #MA
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Primary Responsibilities:

  • Management system audits in HK, China, Macau, and occasionally in other countries/regions. (Primarily remote audits during the pandemic with travel restrictions.)
  • The standards cover ISO 9001, ISO 13485, etc.
  • Other standards may be covered, depending on the candidate's background and qualifications, such as ISO 14001, ISO 45001, IATF 16949, ISO 27001, TISAX, etc.
  • Management role may be offered depending on the candidate's desire and background.

Requirements:

  • Degree holder or higher.  (important)
  • 10+ years' working experience, including 4+ years' in manufacturing field of medical device supply chain.
  • Working experience in EU MDR and FDA CFR-21;
  • Fluent written and oral English and Chinese. (Important)
  • A PECB, Exemplar, DGQ, IRCA, or CCAA certified 5-day ISO 9001 or ISO 13485 Lead Auditor Training Certificate is an advantage, but not necessary.
  • It’s an advantage, but not necessary, if the candidate can provide 2nd or 3rd party audit log for 20 days against ISO 9001 or ISO 13485.
  • Good knowledge in FMEA, SPC and MSA.
  • Either employment or freelance approach.

Remuneration

For employed auditors, the remuneration scheme will include basic salary for employed auditors and extra audit days allowance. For freelance auditors, the service see will be based on audit days.
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Contact

Interested parties, please send your full resume with CURRENT and EXPECTED salaries to hr.hk@dqs.de.

The PRODUCTS of each company you have worked in, and your ROLES shall be described in your resume. If you don’t receive our reply within 2 months, you can consider your application is not successful at present.

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