Senior QARA Engineer - Software

The Senior QARA Engineer - Software at CoMind plays a critical role in ensuring that our medical software complies with regulatory standards. Key responsibilities include developing and implementing quality assurance processes that align with ISO 13485 and FDA regulations, leading validation and verification activities, and supporting documentation for regulatory submissions. This position is essential for maintaining the software's quality and safety that impacts patient outcomes.

To qualify for the Senior QARA Engineer - Software position at CoMind, candidates should have demonstrable experience in quality assurance and regulatory affairs for medical software, a deep understanding of ISO and FDA regulations, and hands-on experience in software validation and verification. Additionally, strong analytical skills and the ability to communicate technical requirements clearly are highly valued attributes.

CoMind is committed to fostering a supportive environment for the Senior QARA Engineer - Software. We provide ongoing training and resources to ensure compliance with evolving industry standards and regulations. Furthermore, our collaborative culture encourages open communication between engineers and QA/RA teams, allowing for continuous improvement in software quality processes.

The work culture at CoMind is vibrant and forward-thinking, embracing innovation with a focus on impact. As a Senior QARA Engineer - Software, you'll find a blend of collaborative team environments and autonomy in your role. We encourage a healthy work-life balance with our hybrid work model and unlimited holiday allowance designed to promote well-being among our employees.

When you join CoMind as a Senior QARA Engineer - Software, you can look forward to a comprehensive benefits package. This includes a company equity plan, pension scheme, private health insurance, unlimited holiday allowance, and much more. We also prioritize mental health support and provide opportunities for professional growth and development.

In answering this question, focus on your hands-on experience with ISO 13485, relating it to your specific roles. Discuss how you've implemented quality management systems, addressed non-conformances, and ensured compliance in software development. Providing examples of how these experiences have led to successful audits can strengthen your response.

When discussing validation and verification, it's important to articulate a systematic approach. Describe your process for creating test plans, executing tests, and documenting results. Explain how you identify risks and develop mitigation strategies, showcasing your attention to detail and commitment to software quality.

Staying updated on regulatory changes is crucial. You can mention your methods, such as attending industry conferences, subscribing to regulatory newsletters, joining professional organizations, and participating in online forums or webinars. Highlight any specific examples of how you've adapted your work based on these updates.

In your response, share a specific example that illustrates your problem-solving skills. Describe the issue, how you addressed it, and the outcomes. Emphasize collaboration with your team and regulatory bodies to ensure compliance while describing any lessons learned from the situation.

Discuss your experience with ISO 14971 and how you've applied risk management principles during software development. Highlight specific methodologies you utilized for risk assessment, risk control measures you've implemented, and how you've communicated risks to stakeholders effectively.

Your answer should elaborate on your systematic approach to documentation preparation, emphasizing attention to detail and systematic organization. Mention how you ensure adherence to regulatory requirements, collaborate with different departments, and perform thorough reviews before submission to avoid delays.

When asked about this, briefly explain the tools and processes you've used for software configuration management. Detail how you successfully managed changes and maintained document traceability, as well as how this contributed to software integrity and compliance.

Communication is key in QA roles. Describe how communicating effectively with software engineers, regulatory affairs teams, and upper management aids in identifying potential issues early, ensuring alignment on quality expectations, and maintaining a clear understanding of compliance requirements throughout the development process.

Discuss your approaches to ensuring cybersecurity in software development, including any frameworks or standards you follow. Talk about previous projects or initiatives you've led to integrate cybersecurity practices and how you educate your team on the importance of this aspect in medical devices.

When answering this question, be authentic and reflect your passion for improving patient outcomes through technology. Discuss specific aspects of CoMind's mission, the innovative project you would be involved in, and the opportunity for personal and professional growth within their forward-thinking team.