Scopio Labs is bringing microscopy into the modern era.
Scopio has developed a breakthrough digital platform based on computational imaging that is capable of scanning microscope slides at the highest resolution on the planet, yet with significantly lower hardware costs than existing solutions. On top of its breakthrough imaging platform, Scopio is building a connected network of microscopy experts and powerful AI-based tools. We’re reducing human error, speeding up turnaround time, and increasing accuracy wherever the microscope plays a role in the diagnostic process.
The QMS lead will be part of the QA Group and will report directly to the QA manager.
We are looking for a Quality Management System (QMS) leader
- Define and maintain the Quality Management System structure to ensure compliance to ISO 13485 and 21 CFR 820.
- Ensure that the Quality Management System is created and maintained in compliance with the appropriate Scopio’s policies, standards and regulations required by the supported products.
- Leads/participates in the maintenance of the quality documents.
- Ensures training and training records as per the QMS and generates training content for local QMS documents as necessary.
- Responsible for periodic reports to Top Management about Quality issues and analysis – MRB, CAPA, ECOs, internal and external audits, and product and process performance.
- Responsible for the internal audits system.
- Responsible for preparations for external audits.
- Establishment and control of traceability system of company product.
- Bachelor’s degree (technical orientation is an advantage)
- 2+ years of experience as a QMS in the medical device industry or other highly regulated field.
- Experience validating application activities.
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
- Experience in undergoing audits.
- Excellent communication, organizational, writing and project management skills.