Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome QA Specialist to join our core QA team that is reshaping MIS.
Supporting in maintenance and management of QA system and document control according to internal and external regulatory requirements. Assistance and execution of QA tasks to enable timely implementation of quality objectives and plan.
- Responsible for implementing most aspects of the quality system including document and data control, supplier monitoring, equipment maintenance, non-conforming materials, incoming and final inspection.
- Maintenance of the company’s documentation related to the QMS.
- Control of traceability system of company product (DMR).
- Responsible for approval of finished product release based on operations record review.
- QA presence on the manufacturing floor.
- Working closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews and deviation issues.
- Responsible for approval of incoming materials based on reviews test results and support records to certify compliance with specifications and procedures.
- Monitoring of subcontractors and control over their performances.
- Support preparation for internal and supplier’s audits as scheduled.
- Monitoring and verification of the effectiveness of quality targets in all areas of QA activity.
- Coordinate equipment maintenance and calibration action activities.
- Maintenance of equipment calibration log.
- Maintain all CAPA, MRB, and ECO Files.
Routine management of all above indicated areas
3+ years relevant experience in the medical device industry including:
guiding of qualification and validation activities (IQ, OQ & PQ , V&V testing, BT) Must be knowledgeable in quality affairs.
Applicable QA procedures:
All QA Procedures, and other quality related documents – specifications, QC documents, working instructions, etc.
Self-reading of all indicated documents.
QA experience in the life science field.