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.

WHAT YOU WILL BE WORKING ON:

• Act as Management Representative responsible for ensuring that the requirements of the quality management system have been effectively defined, documented, implemented, and maintained.
• Act as Person Responsible for Regulatory Compliance (PRRC) responsible for ensuring that the manufacturing and post-market surveillance and vigilances are carried out appropriately.
• Draw up and approve Declarations of Conformity (DoC) that declares the product manufactured by Sibel complies with the essential requirements of the applicable European and international regulations.
• Establish quality objectives at relevant functions and levels within Sibel consistent with the quality policy and ensure that these are periodically reviewed for continued suitability.
• Develop and execute strategic plans to establish, implement, and maintain the Quality Management System (QMS) in compliance with FDA guidances, ISO 13485, and other relevant regulations.
• Lead the development and maintenance of Risk Management Files, including Risk Management Plan/Report, Hazard Analysis, and design/process/use Failure Mode Effect Analysis (FMEA) per ISO 14971.
• Collaborate closely with the Engineering team to ensure design control activities align with internal quality systems, external quality system regulations/standards (e.g., 21 CFR 820 and ISO 13485), and applicable technical regulations/standards.
• Oversee the creation and maintenance of comprehensive documentation (e.g., SOPs, Work Instructions, Records) in accordance with the QMS.
• Coordinate training programs to ensure all stakeholders are proficient in new quality management system revisions and enhancements.
• Manage the onboarding of new equipment, coordinate calibration activities, and maintain accurate records for calibration and preventative maintenance in collaboration with Engineering.
• Supervise receiving activities, including receiving inspection, inventory management, and material transfer to production and R&D departments.
• Provide active support for internal, third-party, and customer audits, as well as management reviews.
• Plan and execute verification and validation activities for products in alignment with regulatory requirements.
• Analyze, develop, and maintain key metrics to evaluate the effectiveness and suitability of the QMS, identifying areas for continuous improvement.

ABOUT YOU:

• Bachelor's degree in an engineering or technical/science field.
• 7 years of experience in quality engineering and/or management systems within the medical device or pharmaceutical industry.
• Expertise in Medical Device Regulations (e.g., FDA 21 CFR Part 820, EU MDR) and related ISO/IEC standards (e.g., ISO 13485, IEC 62304, ISO 14971).
• Demonstrated success in the implementation of a quality management system that has passed certification or regulatory inspections.
• Experience serving as an Lead Auditee or providing support in third-party audits (FDA, Notified Bodies, Competent Authorities, Customers).
• Strong ability to thrive in a matrix organization, effectively communicating with teams at all levels.
• Strong analytical and problem-solving skills, with the ability to analyze data, identify trends, and implement solutions to improve product quality and compliance.
• Detail-oriented and organized, with the ability to manage multiple projects simultaneously and prioritize tasks to meet deadlines in a fast-paced environment.
• Demonstrated leadership and teamwork skills, with the ability to lead and motivate teams, foster a culture of quality and continuous improvement, and drive results.
• Commitment to upholding the highest standards of integrity, ethics, and professionalism in all aspects of the role.

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
• 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