About the Company
This organization employs a remarkable group of biologists, data scientists, engineers, investors, previous caregivers, and general compassionate individuals who have a vision for bringing extremely complex and critical diseases into clear and present focus. For this reason, they will never cease collaborating to improve the strength, speed, and ease of use of their technology, ensuring that every patient who seeks medical attention is promptly diagnosed with and treated for rapidly spreading diseases while there is still time to take action.
Responsibilities:
- Using a biomechanical assessment of white blood cells obtained from a routine blood sample, the test quickly and accurately assesses the risk of sepsis and produces results in less than ten minutes.
- This provides doctors with useful information at the right time, enabling them to reliably and swiftly triage suspected sepsis patients and devote more attention to those who are most in need.
- Additionally, it prevents needless medical intervention, conserves precious resources, and enhances adherence to Sep-1 standards in overburdened health systems.
- In your role as a quality assurance specialist at the company's QMS, you will support the life-cycle of product development and help with a number of quality system processes, such as document control, equipment maintenance, receiving/incoming inspection/release, materials control, CAPAs, deviations, NCRs, training, labels, internal audits, etc.
- As required, offer general assistance for all QMS procedures.
- Handle the DHF index and upload files
- Find areas for process improvement, provide suggestions for fixes, and put modifications into action.
- Create and evaluate measures for quality; As needed, prepare reports.
- Oversee technical reviews and meetings, and bring action items to a finish.
Qualifications:
- Proficiency with Microsoft Office (e.g., Word, Excel, Project, etc.
- Knowledge of regulations and standards such as 21 CFR 820, ISO 13485, ISO 14971, etc
- Candidate should have good organizational skills as well as strong written/verbal communications skills
- Candidate should be able to prioritize tasks, drive process improvements, demonstrate the ability to think critically and thrive in a fast-paced environment
- This position will be based in the South San Francisco Bay area in an onsite work environment
- Ability to work in the United States
