Job Opportunities

Healthcare Consultant

Quality Assurance Specialist – Medical Devices

Experience: 3–6 years
Industry: Medical Devices / Healthcare Technology
Immediate joiners preferred

Role Summary

We are looking for a QA professional with experience in medical device software quality and regulatory compliance**. The candidate should have strong knowledge of ISO 13485, EU MDR, and Software as a Medical Device (SaMD), with hands-on experience in quality management and software validation processes.

Required Skills

* Strong knowledge of ISO 13485
* Good understanding of MDR
* Experience with SaMD / medical device software
* Knowledge of software verification and validation (V&V)
* Knowledge of **ISO 14971**.
* Familiarity with **IEC 62304**.
* Understanding of **IEC 62366** and usability engineering.
* Experience with **FDA 21 CFR Part 820 / QMSR**.
* Experience with regulatory submissions and medical device technical documentation.