(Senior) Software Assurance Engineer SQAE (w/m/d) in Cologne/Berlin

We are Healex, a software start-up and consulting company from Cologne and Berlin, quickly becoming a leading digital health company. Our mission is to develop new products and solutions with your help for faster, data-driven clinical research and for the integration of health and research systems with the “FHIR” data standard.

Healex makes it possible to conduct clinical studies faster, more integrated and even more data-driven with structured clinical data and thereby speeding up the development of new therapies for fatal diseases.

With currently around 20 employees at our two locations, we are looking for one or more experienced (Senior) Software Asssurance Engineers (SQAE).

Your tasks at Healex

  • You improve the quality of our software developments:
    • You will design and coordinate the company's quality assurance processes and advise agile development teams on the further development of their QA procedures
    • You create procedure directories in cooperation with PM
    • You monitor known sources with regard to innovations and changes in legal guidelines and process innovations
    • You maintain the document register and perform general QM monitoring tasks
    • You update training activities of the team members and maintain the employee qualification folder
    • You coordinate audit preparation activities

Your qualifications

  • Ideally, you have at least three years of experience in the pharmaceutical industry, a CRO, CCC, University Hospital, research institute or a digital health start-up as a Software Assurance Engineer, Technical Quality Manager or Test Manager and have worked in software quality assurance or automated testing
  • You have a strong passion for quality assurance and a profound knowledge of QA methodologies, quality management in incident, change management and support processes
  • You have practical experience with GCP and FDA CFR 21 Part 11
  • You speak both English and German fluently
  • A successfully completed degree in (business) computer science/economics, physics or a comparable education is welcome, but not mandatory
  • Optionally, you are also familiar with the following topics and technologies:
    • Building infrastructure for automated software testing
    • Clinical studies (phases I to IV and non-interventional studies), clinical research, pharmaceutical development, (clinical) site management including ICH GCP, applicable regulations and SOPs
    • Clinical data standards: HL7 / FHIR, HL7 / V2

Your way of working

  • You love:
    • Designing strategic overarching themes
    • managing change
  • You can:
    • Work in a process- and goal-oriented manner combined with a strong analytical mind and a high level of quality awareness
    • Be part of a distributed team
    • Work agile
  • You are:
    • open and communicative
    • pragmatic and solution-oriented
    • helpful and uncomplicated
    • curious and eager to learn

We offer you the best working environment

  • You will receive a permanent employment contract with room for your personal development and 30 days of holiday per year
  • From day 1 you take over responsibility at one of the most successful digital health startups with locations in the middle of Cologne and Berlin
  • You work on super exciting, innovative projects in the field of medical technologies and clinical data
  • You can work flexibly – in the office, remote or home office (by arrangement)
  • We provide you with a company laptop, a free annual ticket for local transport and a mobile phone contract
  • Regular team events, flat hierarchies and short decision-making paths in a modern, agile company

We offer you extraordinary challenges and exciting future prospects. We look forward to receiving your online application (cover letter, resume and certificates) to our Head of Software Development Alexander Szabo (jobs@healex.systems), if possible including any links to example code or projects (e.g. on GitHub).

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