Senior Manager Design Quality Assurance

A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we’ve launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

We are looking for a Senior Manager of Design Quality Assurance to join our team. You will report to the Director of Quality and work with cross-functional teams to react quickly and produce quality solutions to difficult technical challenges. Sibel’s fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative design, strong communication skills, teamwork, and more.

This is a full-time position. The salary range for this role is $140,000 - $170,000, depending on level of experience.

WHAT YOU WILL BE WORKING ON:

Leadership and Strategy

• Develop and implement a comprehensive design quality assurance strategy aligned with Sibel Health's mission and goals.
• Lead, mentor, and manage a team of quality assurance professionals, fostering a culture of continuous improvement and excellence.
• Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, product management, and clinical teams to ensure seamless integration of quality assurance processes.

Design Quality Assurance

• Oversee all aspects of design quality assurance activities, including design verification and validation, risk management, and compliance with applicable regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820).
• Ensure robust design control processes are in place, including design reviews, design history files, and design transfer activities.
• Develop and maintain quality metrics, KPIs, and reporting systems to monitor and improve product quality and reliability.

Regulatory Compliance

• Ensure compliance with global regulatory requirements and standards established by agencies, including but not limited to the FDA, EU Commission, TGA, Health Canada, and other relevant regulatory bodies.
• Lead internal and external audits, inspections, and assessments, addressing any findings or non-conformances promptly and effectively.
• Stay abreast of industry trends, regulatory changes, and best practices to ensure Sibel Health's products remain compliant and competitive.

Continuous Improvement

• Drive continuous improvement initiatives in design quality processes, methodologies, and tools to enhance product quality and development efficiency.
• Implement robust corrective and preventive action (CAPA) processes to address product quality issues and prevent recurrence.
• Promote a proactive quality culture throughout the organization, emphasizing the importance of quality in every aspect of product development.

ABOUT YOU:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 8-10 years of experience in design quality assurance within the medical device industry.
• Proven track record of leading quality assurance teams and managing design quality processes for medical devices.
• In-depth knowledge of regulatory requirements and standards (e.g., 21 CFR 820.30, ISO 13485, ISO 14971, ISO 62304, ISO 62366, etc.).
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, leadership, and interpersonal skills.
• Ability to thrive in a fast-paced, dynamic startup environment.

BENEFITS:

• Medical, dental, vision, life, and disability insurance.
• "Take as much time as you need" policy.
• Simple IRA plan with employer matching.
• Company sponsored events and lunches.
• Yearly stipend for professional development.
• Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.