Quality Coordinator

CompanyOverview

Belay Diagnostics is a ground-breaking and enterprising startup organization focused on the non-invasive detection of central nervous system cancers. Belay has partnered with Johns Hopkins, one of the country's leading neuro-oncology research centers, to commercialize proprietary molecular technology that will result in faster, more efficient, and less costly answers for patients with suspicious findings. Our goal is to become a neuroscience center of excellence dedicated to the timely, reliable detection of neurological malignancies and disorders. We hope to serve clinicians seeking a fundamentally better solution to suspicious neurological findings as well as partner with other healthcare entities who will leverage our data to develop much-needed therapeutic solutions for brain cancers. All applicants must be legally authorized to work in the U.S.

Employment Type

Full-time

Job Location

In-Office at our downtown Chicago Headquarters

Essential Duties/ Responsibilities/Requirements

• Responsible for coordination and implementation of the Belay Diagnostics Clinical Laboratory quality program in partnership with the Medical Director, which includes operationalizing laboratory quality initiatives, monitoring quality processes, and ensuring ongoing quality evaluation and improvement
• Supports compliance with clinical lab regulatory standards such as Centers for Medicare and Medicaid Services (CMS), Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and other external agencies overseeing clinical laboratories
• Experience with 510K FDA approval process required
• Works with clinical laboratory leadership to implement performance monitoring and improvement, collects and reports on performance data, develops and supports implementation of corrective action plans, leads process improvement initiatives, and assists in the training and education of personnel regarding quality activities
• Assists in identification and communication of "best practices" in the laboratory to support enterprise standardization and sharing
• Leading proactive laboratory process improvement initiatives, provide feedback on standardization opportunities, evaluate success through pre-established criteria, always working toward a culture of safety
• Continuously monitoring and evaluating laboratory quality and risk performance data across the division, while noting trends and identifying and prioritizing opportunities to improve
• Assisting Medical Director in building a proactive quality department by implementing processes to support accreditation and regulatory inspections
• Promoting a culture that is positive, values individual strengths, takes meaningful risks, and is committed to optimal patient care and compliance with standards
• Practicing and adhering to the "Code of Conduct" philosophy and "Mission and Value Statement"
• Performing other duties as assigned

Education, Knowledge, and Experience

• Bachelor's Degree in a clinical laboratory, chemical, biological science, or related field
• 1+ years of experience in a clinical laboratory (CLIA/CAP)
• 1+ years of quality improvement experience in a clinical laboratory
• MS Office Proficiency (Word, Excel, and PowerPoint)
• Experience with MediaLab Document Control system preferred
• Strong work-ethic , self-motivation, and resourcelfulness
• Strong attention to detail/QC of document content

Belay Diagnostics offers excellent health benefits and a 401(k) program. Belay is a team ofdedicated and collaborative employees committed to improving healthcare.

Belay Diagnostics is proud to be an equal opportunity workplace. All aspects of employment decisions will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of any status protected under federal, state, or local law. We celebrate diversity and are committed to creating an inclusive environment for our colleagues.