Quality Manager

  • Location

    Norderstedt

  • Sector:

    Quality

  • Salary:

    €65,000

  • Contact:

    Luke Fines

  • Job ref:

    22955

Quality Manager (f/m/x)

Location: Norderstedt, Hamburg - Hybrid

Overview:
Our client supports healthcare professionals around the world in lighting the way with diagnostics by providing a broad range of medical diagnostics products and solutions. In the fields of haematology, urinalysis, haemostasis, life science, flow cytometry, essential healthcare and now immunochemistry, they combine highly dependable, multi-functional and easy-to-operate instruments, a variety of reagents and software, plus reliable service and support.

Benefits: 
  • A growing and healthy corporate group with respect and trust as the basis for cooperation and communication As family friendly company we support flexible working time, offer a care allowance for children as well as a parent-child room at our premises 
  • A family atmosphere as well as innovative working in an international environment 
  • 30 days annual holidays as well as Christmas and holiday bonus 
  • Capital-forming benefits and subsidy towards the company pension scheme 
  • Flexible working times/flexitime as well as the possibility of mobile working 
  • Subsidy towards the public transport “ProfiTicket”, free parking for all employees 
  • Diverse range of sport courses in our own fitness studio and massages 
  • Canteen/free beverages/fruit 

Tasks: 
  • Support the maintenance and development of our regional headquarter quality management system (EN ISO 13485) 
  • Maintain, develop and monitor the Quality Management system documentation (e.g. document control, updates of QM documentation) 
  • Support the departments in all QMS-documentation related topics 
  • Monitor and support the departments in design and development activities 
  • Prepare, execute and follow up internal, external and supplier audits 
  • Maintain, monitor and develop our regional product complaint handling process 
  • Maintain, develop and monitor the product related trending process 
  • Execute and monitor the product Change Control process 
  • Lead or participate in quality management improvement projects 

Your Profile:
  • Degree in a relevant discipline, e.g. medical technology
  • At least 3 years of experience in a quality management function in the medical devices industry
  • Substantial knowledge of EN ISO 13485 and knowledge of IVD-R
  • Initial experience in IVD-production environment preferred
  • Experience in product related complaint handling process as well as audit experience
  • Project management skills and experience preferred
  • Process management and improvement skills
  • Excellent command of written and spoken English
  • Good communication skills and the ability to make decisions in a consistent and professional manner
  • Ability to work independently

To apply or for more information please contact Luke via email on: luke.fines@adaptivelifescience.com

#LI-hybrid  #LI-LF1