Qa Specialist Jobs

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 Quality Assurance Specialist to join our team. You will work with hardware, application, and other 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.

WHAT YOU WILL BE WORKING ON:

• Develop process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
• Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions.
• 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.
• Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, utilizing the Agile/Lean methods and traditional project management methods.
• Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, EUMDR, 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 products.
• Work with engineering teams closely to drive quality excellence of digital medical devices, including design reviews, processes/practices simplification, quality system training, etc.
• Lead, develop, communicate & implement a quality and compliance strategy.
• Utilize risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.
• Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the business.
• Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
• Work hands-on with quality and compliance activities around Product Development.
• Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
• Ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.

ABOUT YOU:

• Working knowledge of regional and international quality system requirements including ISO 14971, FDA 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices.
• Effective verbal and written communication skills.
• Experience performing internal audits and participating in external audits.
• Min 6 years of related experience, including 3+ years experience in Quality Assurance and validation.
• Bachelor’s level degree in Science/Engineering or related discipline.
• Attention to detail.

YOU MAY THRIVE IN THIS ROLE IF:

• Ability to use word processing, spreadsheet programs, and email such as MS Office and Excel.
• Working knowledge of regulations, standards and guidelines related to quality.

BENEFITS:

• Stipend for professional development.
• "Take as much time as you need" policy.
• Simple IRA plan with employer matching.
• Medical, dental, vision, life, and disability insurance.
• 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.