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 an experienced Software Quality Specialist to join our team. The ideal candidate will be responsible for ensuring that Sibel software development processes adhere to applicable standards. The candidate will react quickly and produce quality solutions to difficult technical challenges in addition to working with cross-functional teams to ensure the highest level of quality and safety for our medical device software products. 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.

WHAT YOU WILL BE WORKING ON:

• Lead and support the implementation of software development processes and documentation to strict regulatory standard, from software planning to release.
• Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Sibel Health requirements as they relate to the development, verification, validation, maintenance of computerized systems used in the quality system to include those used in the development of software products.
• Work closely with software developers, engineers, regulatory affairs, and quality teams to ensure software quality objectives are met.
• Lead teams in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks.
• Maintain accurate and comprehensive records of all software development and quality activities.
• Create and manage software quality documentation, including design controls, risk assessments, and traceability matrices.
• Utilize risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to Fault Tree Analysis, Failure Mode Analysis, etc.
• Develop, implement, and maintain quality assurance processes to detect and address software defects and deviations, ensuring compliance with all applicable standards.
• Lead teams through Root Cause Investigations, Risk Assessment Reviews, and the development and execution of Corrective and Preventive Actions (CAPA) as needed to monitor and track the timely resolution of nonconformances to meet tight device production and shipping deadlines.
• Support internal and external quality audit.
• Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, utilizing the Agile/Lean methods and traditional project management methods.
• Work hands-on with quality and compliance activities around Software Development Projects.

QUALIFICATIONS:

• Bachelor’s level degree in Computer Science, Software Engineering or related discipline.
• 6 years of related experience, including 3 years’ experience in Medical Device Industry.
• Working knowledge of regional and international quality system requirements including IEC 62304, ISO 14971, FDA 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices.
• Detailed knowledge of Software Development Life Cycle (SDLC) and Data Integrity.
• Strong understanding of quality assurance and quality control principles, methodologies and best practices.
• Experience performing internal audits and participating in external audits.
• Strong analytical and problem-solving skills.
• Effective communication and documentation skills.
• Certification as a Software Quality Engineer (eg ASQ, CSQE) or similar certification is a plus.

BENEFITS:

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

Sibel Health Inc.is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.