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Quality Assurance Specialist - Switzerland  

Company managed [?] Still accepting applications
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Posted on : 10 February 2017

Project Description

About Us:
  • People at our company appreciate the opportunity to shape our future and cre­ate impact. 
  • Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations. 
  • We are currently looking for an enthusiastic Quality Assurance Specialist to join our Supplier & Packaging Compliance Team.
  •  The objective of this function is to ensure external suppliers’ compliance with corporate and regulatory requirements. 
  • The role is focusing on operational tasks in the field of quality assurance and auditing.       

  Your tasks:  
  • Manage the supplier audit program and be responsible for the correct  archiving of the documentation 
  • Track and assess the implementation and completion of audit related  corrective actions / preventive actions (CAPAs) at suppliers 
  • Assess and process product related deviations and non-conformities  reported via the CAPA system 
  • Manage the process validations at the local HQ plant and support  development and production during process validations for new processes  
  • Define or take active part in defining qualification requirements for  suppliers and coordinate the qualification process in collaboration with the  supplier 
  • In case you possess an auditor/lead-auditor certificate, evaluate and  assess the regulatory compliance status of the supplier management by  performing QMS Supplier Audits

Your Profile 
  • Degree in Quality Engineering (preferred) or other relevant area  (engineering, science etc.; advanced graduate studies/degrees are an  advantage) 
  • 2-3 years’ experience within the medical devices/pharmaceutical  industry, desirable at manufacturing site  
  • Expert understanding of global medical device regulations and quality  requirements as well as industry practice 
  • Formal qualification / training / certification on medical devices  regulations such as ISO13485, USA FDA 21CFR Part 820 
  • Auditor or lead auditor experience in audit process is an asset, and  also a development option  
  • Knowledge of regulatory requirements regarding the execution of audits  and the maintenance of Quality Management Systems are an advantage  
  • Process validation experience in development and manufacturing as well  as knowledge of Supplier Management and Purchasing Controls requirements are  highly desired
  • Proven track record in a comparable role within  quality assurance and compliance 
  • Excellent written and verbal communication skills in German  
  • Excellent command of MS Word and MS Excel, familiarity with SAP is an  asset 
  • You are someone who champions customers’ insights leading to concrete  actions 
  • You show honesty, authenticity and demonstrate reliability 
  • You show the ability to be persistent and flexible and know to quickly  adapt to changing demands