Sr./Director, Quality Assurance

The Sr./Director of Quality Assurance at Cleerly is responsible for overseeing product quality, regulatory compliance, and leading the continuous improvement efforts of the Quality Management System (QMS). This includes managing audits, defining quality strategic plans, and ensuring all designs are validated with the appropriate documentation. Additionally, you will mentor a high-performing QA team and collaborate closely with cross-functional teams to integrate quality requirements.

Candidates for the Sr./Director of Quality Assurance role at Cleerly should have a B.S. or higher degree in Engineering or a related field, along with over 15 years of experience in the medical device industry. Certification as an ASQ Certified Quality Engineer or a Lean/Six Sigma Black Belt is preferred. Strong leadership skills and the ability to manage teams and audits are also crucial for success in this role.

The Sr./Director of Quality Assurance plays a vital role in Cleerly's mission to create a new standard of care for heart disease. By ensuring our AI-driven diagnostic solutions are safe and effective, you will directly contribute to our goal of preventing heart attacks and improving patient outcomes. Your leadership in quality assurance will help us stay compliant with regulations and innovate in the healthcare space.

At Cleerly, the Sr./Director of Quality Assurance will enjoy a collaborative and dynamic work environment. Most of our teams work remotely, utilizing digital tools like Google Workspace, Slack, and Zoom to foster communication and innovation. We promote a culture where brainstorming and team collaboration are key to our success, allowing you to contribute meaningfully to product development and quality initiatives.

As a rapidly growing startup, Cleerly offers substantial growth opportunities for the Sr./Director of Quality Assurance. You can take on new challenges, expand your leadership skills, and potentially influence the strategic direction of our quality and regulatory processes. With a strong focus on learning and professional development, Cleerly empowers its employees to advance their careers while making a big impact in the healthcare industry.

In answering this question, focus on specific quality management systems you have worked with, such as ISO 13485, and how you contributed to their implementation and continuous improvement. Discuss any audits you have led or participated in and emphasize your familiarity with regulatory compliance requirements like 21 CFR 820.

Highlight your leadership style, mentioning how you support your team's development and foster a culture of quality excellence. Discuss specific strategies you have employed to mentor team members and how you ensure effective communication within the team.

Talk about your experience developing quality strategic plans and your approach to identifying potential compliance risks. Include examples of how you have successfully integrated quality requirements into product development processes.

Use the STAR method (Situation, Task, Action, Result) to share a detailed example from your past experience. Describe the process you improved, how you identified the need for that improvement, and the positive outcomes that resulted from your actions.

Mention specific resources you use to stay informed, such as industry publications, professional organizations, or networking events. Talk about any training or certifications you've pursued to enhance your knowledge of compliance and quality assurance best practices.

Share examples of times you've worked effectively with teams from different departments, such as R&D or product management. Discuss how you communicated quality requirements and resolved any challenges that arose during collaboration.

Provide insights into your organizational strategies and tools you use to stay productive under pressure. Discuss your experience balancing immediate quality assurance tasks with long-term projects, while ensuring no compromise on quality standards.

Describe the specific steps you took in your previous role to address the situation. Discuss your approach to root cause analysis, communication with stakeholders, and actions taken to prevent future occurrences, showcasing your problem-solving skills.

Explain your understanding of risk management, including methodologies like ISO 14971. Share examples of how you've applied risk assessments to product development, detailing how you've worked to mitigate quality issues proactively.

Share your passion for healthcare innovation and quality assurance, and how Cleerly's mission aligns with your personal values. Discuss why you are drawn to the opportunity to lead a quality assurance team at such a forward-thinking company.