Medical Devices Product Expert & Auditor - China / APAC Region

Medical Devices Product Expert & Auditor – APAC

Type; Permanent.

Salary: Negotiable.

Location: Home/Office Based China or Japan.

Travel: Yes, 20%.

Purpose:

The Medical Team is geared towards worldwide certification of medical devices and quality systems.

The role:

An expert in testing and inspection, a company with a real passion for safeguarding quality and safety in the area’s of technology, mobility and environment. With a presence in over fifty countries they are one of the largest players in the industry.

Your tasks

• You are responsible for the assessment of technical files and the auditing of the quality system of your customers (from high innovative start-ups to large multinationals, both national and international)


• You act as a linchpin and maintain frequent contact with your customers, colleagues, external experts like physicians, contractors and authorities


• You will have the opportunity to represent the business at conferences


• The position entails travelling within and outside Europe, approximately 20-30% of the time

Your skills:

• Higher vocational or university level education, in life and/or engineering sciences.


• A minimum of 4 years of full time work experiences in medical device related industry, including at least 2 years in R&D, QA/RA.


• Experienced in at least one of the following devices categories and areas of expertise: soft tissue implants, cardiovascular devices, drug device combinations, animal tissue and IVD.


• Experience with quality management systems and relevant laws and regulations, at least CE.


• Project management and auditing experience is considered an advantage certification. We are part of the international assessment

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