Director of Software Quality Assurance

  • 130 EUR - 150 EUR
  • München, Germany
  • Permanent
Director of Software Quality Assurance

Position summary: in this role, you have the opportunity to
Play a key role in a high-paced Medtech startup company aiming to disrupt a billion-dollar industry and touch millions of lives by developing a next-generation diagnosis & therapy solution for Atrial Fibrillation (AF), a cardiac disease affecting the life of more than 38 million patients worldwide.

You will be responsible for leading and managing all aspects of software V&V, risk management, and cybersecurity in a dynamic medtech environment. Your role will be crucial in ensuring the delivery of high-quality, reliable, and secure software solutions that map and visualize the patient’s heart anatomy, identify drivers of atrial fibrillation, and support the physician with navigating catheters and delivering therapy to treat the disease. The system will be built upon an existing solution that has already obtained FDA clearance and CE mark.

We are interested in candidates who have the entrepreneurial mindset, agility and flexibility required to be successful in a high-paced startup. Working location: Munich, Germany. For exceptionally qualified candidates, a remote or hybrid working location may be considered.

Your key responsibilities include:
  1. Test Management:
    1. Oversee and manage the software test team.
    2. Ensure effective planning, execution, and documentation of software V&V activities on the system, integration, and unit level.
    3. Develop and implement automated testing strategies to enhance V&V efficiency and effectiveness.
  2. Risk Management:
    1. Lead and conduct risk assessments and contribute to the identification and mitigation of software-related risks throughout the lifecycle.
    2. Collaborate with cross-functional teams to identify and address potential risks.
  3. Cybersecurity:
    1. Drive the implementation and enforcement of cybersecurity policies and procedures.
    2. Stay abreast of the latest trends and regulations in software security.
  4. Team Leadership:
    1. Build, mentor, and lead a high-performing QA team.
    2. Facilitate continuous learning and development.
  5. Quality Standards and Regulatory Compliance:
    1. Ensure software quality processes comply with relevant regulatory standards, including FDA, ISO, and other applicable regulations.
    2. Review technical documentation for completeness, correctness, and compliance.
  6. Process Improvement:
    1. Continuously improve QA processes and practices, incorporating best practices and new technologies.
    2. Stay abreast of industry trends and best practices in software quality assurance.
  7. Stakeholder Collaboration:
    1. Work closely with other departments, including software development, quality and regulatory affairs, and product management, to ensure alignment of QA objectives.
    2. Collaborate with the software development team to integrate quality assurance practices throughout the software development lifecycle.
To succeed in this role, you should have the following skills and experience
  • Bachelor's or master's degree in computer science, engineering, or related field.
  • Extensive experience in software quality assurance within the medical device industry.
  • Proven track record in managing verification activities and leading QA teams.
  • Strong knowledge of risk management and cybersecurity in software development.
  • In-depth knowledge of med tech industry standards and regulations for medical device software including IEC 62304 and ISO 14971.
  • Excellent leadership, communication, and interpersonal skills.

Christian Bulz Division Director

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