Job Role: 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 robust 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
Robust knowledge of ISO 13485
Positive 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.

Pay: ₹30,000.00 - ₹60,000.00 per month

Education:
Bachelor's (Preferred)

Experience:
ISO 13485: 4 years (Preferred)
total work: 5 years (Preferred)
SaMD: 3 years (Preferred)

Work Location: In person

📌 Quality Assurance Specialist Medical Device Kochi
🏢 iCodeBees Private
📍 Kochi