Althion
Website:
althion.in
Job details:
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 regulatory and certification gap assessments and prepare actionable compliance plans.
- Coordinate with external testing laboratories, consultants, certification bodies and, where applicable, Notified Bodies.
- Work with engineering teams to prepare products for electrical safety, EMC and other applicable compliance testing.
- Support preparation and maintenance of Design History Files, Device Master Records, Technical Documentation/Technical Files and certification records.
- Prepare and maintain risk-management documentation including hazard analysis, risk evaluation, risk-control measures and traceability.
- Establish and maintain software lifecycle documentation under IEC 62304, working directly with firmware/software developers.
- Review engineering changes for their regulatory, risk-management and certification impact.
- Support design controls, verification, validation, CAPA, change control, non-conformance and document-control processes.
- Support preparation of EU MDR Technical Documentation, GSPR checklists and supporting evidence.
- Assist with CDSCO licensing, amendments, renewals and other Indian regulatory submissions.
- Maintain a clear certification tracker covering requirements, documentation gaps, testing status, responsible persons, deadlines and open actions.
- Provide regular progress reports to management and proactively escalate certification risks or delays.
Candidate Profile
- 2–6 years of relevant QA/RA, medical-device certification or compliance experience.
- Degree in Biomedical, Electronics, Electrical, Instrumentation, Mechanical Engineering or another relevant technical discipline.
- Practical exposure to medical-device standards and regulatory documentation.
- Experience with IEC 60601 and/or IEC 62304 is strongly preferred.
- Understanding of ISO 13485 and ISO 14971.
- Exposure to EU MDR, CDSCO/MDR 2017 or international medical-device regulatory submissions is desirable.
- Ability to understand technical drawings, electronics, firmware/software architecture, test reports and engineering documentation.
- Strong documentation, project-tracking and follow-up skills.
- Comfortable working directly with engineers and translating regulatory requirements into specific engineering actions and evidence.
- Proactive and capable of independently following up with internal teams, laboratories, consultants and certification agencies until activities are completed.
What We Are Looking For
We are particularly interested in candidates who are hands-on and execution-oriented. The successful candidate should be able to take a requirement such as IEC 62304 or IEC 60601, identify what is missing, work with the engineering team to close the gaps, coordinate testing/documentation, and systematically drive the certification process toward completion.
This is an in-office position in Hyderabad and can be structured as either a full-time or part-time role depending on the candidate's experience and availability.
WHAT WE OFFER
- Attractive compensation package
- Performance-linked incentives
- ESOP opportunities for suitable candidates
- Opportunity to build domestic and international markets for innovative laboratory and ultrapure water systems
Candidates may apply directly through LinkedIn with their updated CV.
Click on Apply to know more.
