Software Quality Engineer IV

As a Software Quality Engineer IV at Beacon Biosignals, you'll be responsible for integrating quality practices into software development and machine learning teams. Your role will involve maintaining compliance throughout the product lifecycle, providing essential training on SDLC practices, representing the company during audits, and fostering collaboration across teams to enhance overall product quality and alignment with regulatory obligations.

To qualify for the Software Quality Engineer IV position at Beacon Biosignals, you should have a minimum of 5 years of experience within a software quality environment in the medical device industry. Additionally, you will need a Bachelor’s degree in a relevant field, certification as a Software Quality Engineer (CSQE), and a strong understanding of key industry standards such as IEC 62304, ISO 13485, and 21CFR 820.

Success as a Software Quality Engineer IV at Beacon Biosignals requires strong analytical and problem-solving skills, exceptional organizational capabilities, and the ability to adapt to changing circumstances. Additionally, interpersonal relationship-building to manage internal and external stakeholders effectively is crucial, along with the ability to contribute positively to the organization’s goals and foster a culture of quality.

The working environment for a Software Quality Engineer IV at Beacon Biosignals supports both remote and in-office work, allowing for flexible asynchronous work practices. You will be part of a collaborative team that values communication, innovation, and quality, contributing to ensuring that our projects meet the highest standards and regulatory compliance.

At Beacon Biosignals, we prioritize professional growth by providing opportunities to lead initiatives, offer company-wide training on best practices in quality, and keep you informed about the latest international regulatory changes. We encourage innovation and intellectual curiosity, ensuring that you can continuously learn and evolve in your role as a Software Quality Engineer IV.

When answering this question, highlight your familiarity with the standard's requirements for software lifecycle processes, and provide specific examples of how you've implemented IEC 62304 in past roles, particularly in ensuring compliance, managing risk, and promoting effective software development practices.

To respond effectively, choose an incident where your analytical skills led to the early identification of a potential compliance issue. Outline the steps you took to address it and how your actions prevented it from affecting the project or product, emphasizing communication and collaboration with your team.

Discuss your approach to integrating quality practices throughout the SDLC, including specific tools or methods you've utilized for testing, validation, and continuous improvement, showcasing your ability to maintain high standards while promoting agile methodologies.

Explain your proactive approach to staying informed about changes in industry regulations and standards. Mention resources you use such as relevant publications, online courses, participation in professional organizations, or networking within the industry to keep your knowledge fresh and applicable.

Choose a project that involved complex compliance requirements or high-stakes deliverables. Detail the challenges faced, your role in leading the project, the strategies you employed to overcome difficulties, and the successful outcomes achieved, demonstrating your leadership and problem-solving capabilities.

Discuss your experience in developing training materials or conducting workshops that explain key quality standards and best practices. Provide examples of successful training initiatives that led to improved team compliance and performance.

Describe your experience in preparing for and participating in audits, focusing on your organizational skills, attention to detail, and ability to collaborate with teams to gather necessary documentation and ensure compliance is maintained throughout the audit process.

Emphasize your strategies for fostering communication and collaboration in a remote setting, such as utilizing project management tools, regular virtual check-ins, and facilitating a culture of transparency and engagement to ensure the quality team remains aligned with broader organizational goals.

Discuss your conflict resolution skills by outlining methods you've successfully employed to prioritize tasks, communicate effectively with the involved parties, and find a resolution that aligns with the quality objectives while respecting the needs of all teams involved.

To showcase your fit, reflect on your relevant experience, personal passion for quality in the medical device industry, and alignment with Beacon Biosignals' mission. Highlight your ability to adapt to dynamic environments and your commitment to fostering a culture of quality that enhances patient outcomes.