RA/QA Engineer: Medical devices

<p>ABOUT ALTHION</p><p>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.</p><p>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.</p><p><br></p>QA/RA Engineer – Medical Devices<p><strong>Quality Assurance & Regulatory Affairs</strong></p><p><strong>Location:</strong> Hyderabad, Telangana – In-office</p><p><strong>Employment:</strong> Full-time / Part-time</p><p><strong>Experience:</strong> 2–6 years</p><p><strong>Industry:</strong> Medical Devices / Healthcare Technology</p>About the Role<p>We are looking for a <strong>QA/RA Engineer</strong> 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.</p><p>The role will work closely with our <strong>R&D, firmware, electronics, mechanical, manufacturing and management teams</strong> to ensure that products and their technical documentation meet applicable Indian and international regulatory requirements.</p><p>A major responsibility will be <strong>driving certification projects to closure</strong> rather than only maintaining documentation.</p>Key Responsibilities<ul><li>Plan, coordinate and track product certification and regulatory activities from <strong>gap assessment through testing, documentation, submission and closure</strong>.</li><li>Support compliance with applicable standards and regulations including:</li><li><strong>IEC 60601-1</strong> – Medical electrical equipment – Basic safety and essential performance</li><li>Applicable <strong>IEC 60601-1-X collateral and 60601-2-X particular standards</strong></li><li><strong>IEC 62304</strong> – Medical device software lifecycle processes</li><li><strong>ISO 14971</strong> – Medical device risk management</li><li><strong>IEC 62366-1</strong> – Usability engineering</li><li><strong>ISO 13485</strong> – Medical device quality management systems</li><li><strong>EU MDR 2017/745</strong></li><li>Indian <strong>Medical Devices Rules (MDR 2017) / CDSCO</strong> requirements</li><li>Determine applicable standards and regulatory requirements for new and existing products.</li><li>Conduct <strong>regulatory and certification gap assessments</strong> and prepare actionable compliance plans.</li><li>Coordinate with external testing laboratories, consultants, certification bodies and, where applicable, Notified Bodies.</li><li>Work with engineering teams to prepare products for <strong>electrical safety, EMC and other applicable compliance testing</strong>.</li><li>Support preparation and maintenance of <strong>Design History Files, Device Master Records, Technical Documentation/Technical Files and certification records</strong>.</li><li>Prepare and maintain risk-management documentation including hazard analysis, risk evaluation, risk-control measures and traceability.</li><li>Establish and maintain <strong>software lifecycle documentation under IEC 62304</strong>, working directly with firmware/software developers.</li><li>Review engineering changes for their regulatory, risk-management and certification impact.</li><li>Support design controls, verification, validation, CAPA, change control, non-conformance and document-control processes.</li><li>Support preparation of <strong>EU MDR Technical Documentation</strong>, GSPR checklists and supporting evidence.</li><li>Assist with CDSCO licensing, amendments, renewals and other Indian regulatory submissions.</li><li>Maintain a clear <strong>certification tracker</strong> covering requirements, documentation gaps, testing status, responsible persons, deadlines and open actions.</li><li>Provide regular progress reports to management and proactively escalate certification risks or delays.</li></ul>Candidate Profile<ul><li><strong>2–6 years of relevant QA/RA, medical-device certification or compliance experience.</strong></li><li>Degree in <strong>Biomedical, Electronics, Electrical, Instrumentation, Mechanical Engineering</strong> or another relevant technical discipline.</li><li>Practical exposure to medical-device standards and regulatory documentation.</li><li>Experience with <strong>IEC 60601 and/or IEC 62304</strong> is strongly preferred.</li><li>Understanding of <strong>ISO 13485 and ISO 14971</strong>.</li><li>Exposure to <strong>EU MDR, CDSCO/MDR 2017 or international medical-device regulatory submissions</strong> is desirable.</li><li>Ability to understand technical drawings, electronics, firmware/software architecture, test reports and engineering documentation.</li><li>Strong documentation, project-tracking and follow-up skills.</li><li>Comfortable working directly with engineers and translating regulatory requirements into <strong>specific engineering actions and evidence</strong>.</li><li>Proactive and capable of independently following up with internal teams, laboratories, consultants and certification agencies until activities are completed.</li></ul>What We Are Looking For<p>We are particularly interested in candidates who are <strong>hands-on and execution-oriented</strong>. 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.</p><p><strong>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.</strong></p><p><br></p><p><span class="ql-cursor"></span>WHAT WE OFFER</p><ul><li>Attractive compensation package</li><li>Performance-linked incentives</li><li>ESOP opportunities for suitable candidates</li><li>Opportunity to build domestic and international markets for innovative laboratory and ultrapure water systems</li></ul><p>Candidates may apply directly through LinkedIn with their updated CV.</p><p><br></p>

Back to blog

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...