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Head of Quality Assurance (m/f)

Definiens, Definiens AG Munich

Leading a new front against cancer


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 in our Munich HQ office.

 

 Responsibilities

  • 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. For more information, please visit: www.definiens.com

For more information, please watch the following video to get an impression on how it's like to work at Definiens, in the product development department: https://youtu.be/W0d_B1WXsCU

 

Data Protection Policy (Greenhouse Software Inc. Services) full version:

Please have look under http://www.definiens.com/legal/data-protection-policy

 

About Definiens

We improve patient lives by unlocking the tissue phenome In oncology, therapeutic strategies have shifted from a direct assault on cancer cells to recruiting the immune system for that purpose. Our mission is to accelerate breakthroughs for this approach by helping scientists leverage Tissue Phenomics to deepen understanding of disease biology and immune system mechanisms, to bring multi-omics data into a cancer-relevant context, and to facilitate the translation of new insights into novel therapies and treatment strategies. Our vision is to create unique patient profiles for an individualized standard of care, where patients experience fewer side effects and live longer. Discover more. We offer a powerful quantification system to transform tissue image data into insights, paired with unique data-mining methods that open new opportunities for biomarker discovery. Integrate all. Our work is the essential link to integrate all ‘omics data with clinical outcomes. We bridge molecular events and phenotypic effects to create validated tissue signatures that match patients and therapies. Rely on us. From the seed of an idea to its launch as a product, we support every step with meaningful knowledge and powerful tools that advance drug or diagnostic development and their transfer to the clinic. How we partner Our work model builds on a simple premise: Tissue Phenomics strengthens results, from biomarker discovery to clinical development and meaningful diagnostics. We bring Tissue Phenomics to you, seamlessly integrate into your processes, and act as your reliable, science-driven partner along the way. Our history Taking a ground-breaking technology that dramatically improves the information that can be extracted from histological images, Nobel Laureate Dr. Gerd Binnig founded Definiens in 1994. The goal? To create new opportunities for discovery and advances in oncology and immuno-oncology. Since then, Definiens technology has been used in thousands of projects, yielding results that have accelerated drug development and produced over 650 peer-reviewed publications. In 2013, Frost and Sullivan recognized Definiens as Company of the Year for Global Tissue Diagnostics and Pathology Imaging. Definiens is now an international company with over 100 employees worldwide, and headquartered in Munich, Germany and Cambridge, USA.

Want to learn more about Definiens? Visit Definiens's website.