Sr. Manager Design Quality Assurance
Join Sibel Health and help deliver Better Health Data for All®.
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
- Develop and implement a comprehensive design quality assurance strategy aligned with Sibel Health’s mission and goals.
- Mentor and provide guidance to 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.
- 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.
- Lead internal and external audits, inspections, and assessments, addressing any findings or non-conformances promptly and effectively.
- 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.
- Up to 10% international travel required.
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.