ABOUT ALTHION
Althion is a Hyderabad-based med-tech and water-tech company developing and manufacturing medical devices, laboratory water-purification systems, ultrapure water systems, dialysis water-treatment systems, and related equipment.
With its initial R&D; and manufacturing set-up funded by BIRAC and growing market traction in India, Althion is expanding its domestic and international presence.

QA/RA Engineer – Medical Devices
Quality Assurance & Regulatory Affairs
Location: Hyderabad, Telangana – In-office
Employment: Full-time / Part time
Experience: 2–6 years
Industry: Medical Devices / Healthcare Technology
About the Role
We are looking for a QA/RA Engineer to support the quality, regulatory and product-certification activities for our medical-device portfolio, including dialysis water-treatment systems and other electromechanical/electronic medical equipment.
The role will work closely with our R&D;, firmware, electronics, mechanical,



manufacturing and management teams to ensure that products and their technical documentation meet applicable Indian and international regulatory requirements.
A major responsibility will be driving certification projects to closure rather than only maintaining documentation.
Key Responsibilities
Plan, coordinate and track product certification and regulatory activities from gap assessment through testing, documentation, submission and closure.
Support compliance with applicable standards and regulations including:
IEC 60601-1 – Medical electrical equipment – Basic safety and essential performance
Applicable IEC 60601-1-X collateral and 60601-2-X particular standards
IEC 62304 – Medical device software lifecycle processes
ISO 14971 – Medical device risk management
IEC 62366-1 – Usability engineering
ISO 13485 – Medical device quality management systems
EU MDR 2017/745
Indian Medical Devices Rules (MDR 2017) / CDSCO requirements
Determine applicable standards and regulatory requirements for new and existing products.
Conduct r

📌 RA/QA Engineer: Medical devices (Hyderabad)
🏢 Althion
📍 Hyderabad