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Experienced SW Product Quality Manager for innovative 3Shape

To strengthen the quality assurance in agile development projects

For our client 3Shape we are looking for an experienced Product Quality Manager who wants to be strongly involved in all phases of the software development life cycle.  
3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. The portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market leading scanning and design software solutions for dental labs. 
Two graduate students founded 3Shape in Denmark’s capital in the year 2000. Today, 3Shape has over 1,300 employees serving customers in over 100 countries from an ever-growing number of 3Shape offices around the world. www.3shape.com ;
You work with the project on the practical interpretation and implementation of company QMS processes and regulatory standards. You leverage quality assurance experience across projects and review the project documentation and technical file on an ongoing basis in order to prepare for a smooth and fast phase transitions. You work together with Regulatory Affairs to identify the regulatory documentation required for market access and the quality documentation needed for a smooth transfer of new products from development to production. In collaboration with the project manager you plan how and when the required documentation is produced. It’s your responsibility to react on possible QA/QMS knowledge gaps and arrange training sessions. 
Your Qualifications and Personality  

  • Master/bachelor degree in Computer Science or similar 
  • 3+ years of experience working with quality assurance of software as a medical device (13485, 62304, 14971, FDA QSR, experience with MDD/MDR would be considered a plus) 
  • 3+ years of hands on coding from larger scale projects 
  • Fluent in English with good oral and written communication skills 
  • Structured and excellent at planning  
  • Ability to work independently but also as a team player 
  • Motivated by a dynamic, fast moving organization 
  • A positive and solution- oriented mindset   

A Job with Many Benefits  
Beyond the cool technical playground of your everyday work, joining the 3Shape fold comes with social and financial perks, including:  

  • Competitive packages to keep you feeling valued 
  • Paid parental leave after ten months seniority 
  • Healthcare package to keep you fit and well 
  • Breakfast, fruit, snacks and hot beverages to keep you fuelled 
  • Fresh lunch cooked by resident chef in new canteen to make you smile 
  • Seasonal parties to keep you connected with colleagues (and hopefully dancing) 
  • Wine and beer club to keep   

Please do not hesitate to send your application and CV to Bloom via the "Ansøg" link. We are constantly evaluating applicants, and look forward to hearing from you. 

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