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Head of Quality Assurance (m/f) - Germany  

Definiens (company)


Posted on : 08 June 2017

Project Description

For the earliest possible start date we are searching for a highly qualified and motivated Head of Quality Assurance (m/f) to join our expanding Quality Assurance team.

  • Provide leadership to the Product Development department with respect to Software Quality 
  • Direct line management of the Quality Assurance team 
  • Prepare and drive execution of Quality Assurance strategy 
  • Install test metrics and measurements for continuous monitoring 
  • Educate and drive motivation of all members that are part of the SDLC with respect to verification and validation and test automation 
  • Implement/make changes to SOPs and Work Instructions related to software verification and validation to meet regulatory standards (GxP, medical device) 
  • Contribute to medical device submissions (FDA, CE-IVD) 
  • Management of requirements for IT resources to ensure high degree of productivity and process automation (e.g. tool evaluation, hardware requirements, cloud infrastructure requirements) 
  • Nurture a continuous improvement culture 
  • Work together with operations team to ensure proper verification and validation of production system 

Qualifications & Skills                                          
Education / experience
  • Master or PhD in Computer Science or similar qualification with 3+ years of working experience in the biomedical industry or alternatively Master/PhD in Biology or Medical Doctor with 5+ years of working experience in computer science/IT 
  • 5+ years setting up and  leading a high performing test automation and Quality Assurance team 
  • 5+ years successfully managing the quality across the supported products 
  • Managed a quality assurance team in a regulated environment, and led the team thru a successful submission of a medical device and/or the implementation of a  GxP compliant system/process 
  • Ideally education as SCRUM Master or Kanban Coach 

Technical Skills 
  • Profound understanding of all dimensions of quality metrics 
  • Programming test automation procedures 
  • Testing (REST) APIs 
  • Load and performance tests 
  • Cloud infrastructure tests (e.g. AWS) 
  • (Web) security tests 
  • Automatic web UI test frameworks 
  • Databases and content management systems 
  • Application Lifecycle Management and test management software, ideally in medical device context (e.g. Polarion, Jama) 
  • Issue tracking tools (e.g. Jira) 
  • Continuous integration and continuous delivery tools (e.g. Jenkins, Buildbot) 
  • Linux and Windows environments 
  • Relevant regulatory standards (e.g. ISO 13485, IEC 62304, IEC 82304, 21 CFR part 820, 21 CFR part 11, GAMP5, GCP) 

Other Skills and Competencies
  • Combines fast and flexible thinking with high degree of diligence 
  • Can think globally and locally, abstract and concrete 
  • Can put high level and complex problems into a prioritized plan 
  • Excellent team player, motivates people 
  • Passion to get things done 
  • Excellent communication (written and oral) and presentation skills 

We offer
  • This is a challenging and rewarding position within a pioneering company that works with cutting edge technologies. 
  • We offer a modern, creative and international working environment with highly motivated and well-qualified colleagues, team spirit and excellent working conditions with comprehensive benefits and ongoing professional development opportunities.