QMS Engineer

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Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ 11,000 people worldwide. Our broad portfolio of hearing related products and services generates annual revenues of around EUR 1.7 billion.

 Basic Purpose of the role 

  1. Support Company compliance of ISO 13485/9001 and regulations.
  2. Support the QMS requirement implementation effectively.
  3. Support the internal & external audit and continuous improvement. 

 

Key Responsibilities

 

1.   Quality management system maintenance and continuous improvement.

  • To support on the internal audit of quality management system and ensure the effectiveness of quality management system.
  • Monitor the latest requirement of ISO ISO9001 & ISO13485 and the Chinese Medical device regulation and implement in company.
  • Follow up the actions from management review, internal and external audit and quality improvement activities to coordinate quality management system continuous improvement.
  • Follow up the implementation of relevant corrective and preventive action and verify the effectiveness.


2.    Certification of quality management system & Regulation and customer audit

  • Keep good communication with certify body & authority and customer.
  • Support the 3rd party audit and customer audit.
  • Review the lobal documents to ensure aligned with global QMS requirement and meet relevant Standards & Regulation requirement.
  • Support for document control including the documentation and records..


3.     QMS Document Review and Control

  • Review the lobal documents to ensure aligned with global QMS requirement and meet relevant Standards & Regulation requirement.
  • Support for document control including the documentation and records..
  • Training
  • Fulfil Other tasks assigned by manager, eg, the EHS relevant, global communication, etc. 
  • Support the training program in company level.
  • Be responsible for the training of QMS related documents.

 

Education | Qualification

 

  • Bachelor degree or above, majoring in electronic, electromechanical or quality engineering; 
  • At least 2 years’ relevant working experience in foreign medical company.
  • Continuous improvement project experience of multi-departments.
  • Good to have QMS internal auditor certification.
  • Good English skill in both written and oral. 

Or, know someone who would be a perfect fit? Let them know!

Suzhou

Sutong Road
215017 Suzhou Shi Directions

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