QA/QC Lead

Company Description

ELEM is a cutting‑edge in silico startup developing virtual human digital twin technology to transform the future of healthcare. As part of our Compliance team, the Quality Assurance & Regulatory Officer (QARO) ensures that our solutions, processes, and documentation meet all applicable quality and regulatory requirements.

Quality Control, Non‑Conformities & Continuous Compliance

• Handle non‑conformities and deviations end‑to‑end, including documentation, investigation, and root cause analysis.
• Define, implement, and routinely monitor quality controls throughout the product lifecycle.
• Review and confirm that manufactured software versions meet conformity requirements before market release.

Document Control, Traceability & Complaint Handling

• Manage traceability, storage, and controlled handling of quality documents and complaints.

Regulatory Monitoring & Docume...