QMS Team Lead

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WS Audiology

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. Learn about us on www.wsa.com

The Role

As our talented QMS Team Lead, you will lead our QMS team, and guide the team in all quality related activities. You will take ownership of our resources and expenses while ensuring Local Documentation Control. You will also aid the support of Quality Improvement activities within WSAudiology´s affiliates

Your responsibility

You will primarily:

  • Maintain the Quality Management System according to ISO 13485 and 21 CRF part 820 at the affiliate in Lynge
  • Lead the QS team in Lynge (to define training needs, support, transparent communication)
  • Ensure people management and development
  • Communicate and life the cultural values of WSAudiology and the global QMS team
  • Conduct regular meetings with local Departments to share and to discuss quality relevant topics
  • Take leadership of the team in regards to development of individuals and creation of responsibility and independent realization of QMS tasks
  • Maintenance of Documentation Control for local QMS documents                    
  • Closed cooperation with global documentation control officer and local doc control officer from other affiliates
  • Closed cooperation with the global QMS teams                                       
  • Monitor and to track action items from Management Reviews (local, global, WSA affiliates)
  • Ensure closed contact with affiliates worldwide in regards to Quality Improvement activities and initiatives                                                                                                     

Candidate Profile

  • Have strong knowledge of GMP, ISO 13485, CFR 21 part 820, ISO 45001, EH&S requirements
  • Have license as internal auditor
  • Experience in People Management, Functional Organization Management
  • Have strong Process Management and Communication Skills     
  • Experience in Statistical Analysis, Six Sigma or similar            
  • Previously worked with Medical device requirements            
  • Have good presentation and hands on training capabilities
  • Team Player with strong stakeholder management 

Interested in Quality but looking for different challenges: Check out out our Regional Quality Training Officer - EMEA         

Join WS Audiology

We will be conducting interviews on a continuous basis, so please send your CV and application as soon as possible and no later than 30th April , 2021.   

Usually responds within two weeks

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

Lynge / Greater Copenhagen Area

Nymøllevej 6
3540 Lynge Directions

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