Qms Quality Engineer

Role & responsibilities

Manage certification activities for medical and industrial products.

Coordinate with certification bodies for approvals, registrations, licensing, and compliance requirements related to radiology and X-ray equipment.

Prepare, review, and maintain technical documentation required for regulatory submissions.

Liaise with testing laboratories, certification agencies, and government authorities.

Monitor changes in regulatory requirements and ensure timely implementation.

Conduct compliance gap assessments and risk evaluations.

Support product development teams in meeting regulatory and safety requirements.

Maintain compliance records, test reports, declarations, and certification databases.

Assist in audits, inspections, and regulatory reviews.

Coordinate with customers and OEMs regarding regulatory documentation and approvals.

Ensure compliance with applicable standards related to medical electrical equipment, radiation safety, and quality management systems.

Preferred candidate profile

B.E./B.Tech in Electronics, Electrical, Biomedical Engineering, Instrumentation, or related disciplines.

28 years of experience in Regulatory Compliance, Medical Equipment, Radiology Equipment, Medical Devices, or X-ray Systems.

Experience handling BIS, AERB, CDSCO, or similar regulatory requirements will be preferred.