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Quality Assurance Manager for Central Europe Munich Germany,  

Bio-Rad (company)


Posted on : 27 March 2017

Project Description


Job Description 
   
  • Provides leadership and strategic direction for the Quality Management System in compliance with European and FDA requirements for in-vitro diagnostic products. 
  • Implementation and maintenance of local Quality Management System in accordance with the Global RA/QA strategy and in compliance with European and FDA requirements. 
  • This includes among other things systems and processes for:    
    • Quality Improvement 
    • Document Control 
    • Audits 
    • CAPA 
    • Nonconforming Products/OOS 
    • Change Control 
    • Complaint Handling 
    • Design Control 
    • Risk Management 
    • Management Review  
  • Batch Record Review and Batch Release 
  • Offer quality related training for Munich site 
  • Execution of internal audits as lead auditor for the site 
  • Quality contact for authorities and notified bodies 
  • Management of notified body or authority audits       



Required Skills   
Analytical (thinking) skills Independent working style Fluent English-speaking         




Required Experience   
  • Bachelor s or Master Degree in Science 
  • A minimum of eight 8 years, with direct responsibility for Quality Management Systems and related compliance to current Quality Systems Regulation and other relevant standards (e. g. ISO 9001).  
  • Knowledge of QMS requirements applying to in vitro diagnostic products 
  • Quality Engineering and /or Six Sigma Black Belt certification preferred.               

Locations

Muenchen Germany

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