Quality Engineer - PMS

Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><h3><b>What you will do- </b></h3><h3></h3><div><ul><li><h3><span><span>P</span><span>erform preliminary complaint intake, management, and event classification.</span></span><span> </span></h3></li><li><h3><span><span>Conduct customer follow-ups and assess complaints for regulatory reportability<span> </span></span><span>in accordance with</span><span><span> </span>FDA 21 CFR 803, EU MDR 2017/745, and ISO 13485. </span></span><span> </span></h3></li><li><h3><span><span>Prepare and submit MDR, MIR, vigilance, and global adverse event reports, achieving zero late submissions.</span></span><span> </span></h3></li><li><h3><span><span>Collaborate closely with stakeholders and team members, providing guidance and coaching to drive engagement and performance.</span></span><span> </span></h3></li><li><h3><span><span>Demonstrate strong knowledge of Post-Market Surveillance requirements (US FDA and EU MDR), Quality Management Systems (ISO 13485, 21 CFR 820), and complaint handling tools such as<span> </span></span><span>TrackWise</span><span><span> </span>or equivalent systems.</span></span><span> </span></h3></li><li><h3><span><span>Experience with<span> </span></span><span>TrackWise</span><span><span> </span>and Microsoft Project</span></span><span> ; </span><span><span>Post Market Surveillance as per US FDA &amp; EU MDR</span></span><span> ; <span>Quality Management (ISO 13485 or 21 CFR 820 ; working with multiple teams and collaborating across geographically spread multi-functional teams.</span></span><span> </span></h3></li><li><h3><span><span>Understanding on Medical Device Risk Management</span></span><span> </span></h3></li></ul></div><h3></h3><h3></h3><h3><b>What you will need-</b></h3><h3></h3><h3><b>Required-</b></h3><div><div><ul><li><h3><span><span>​</span><span><span>BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes</span></span></span><span> </span></h3></li><li><h3><span>Experience- 2years to 5 years</span></h3></li><li><h3><span><span>​</span><span><span>1</span><span>-</span><span>2</span><span><span> </span>years of experience in Medical Device domain; </span></span></span><span><span><span>At least<span> </span></span><span>1</span><span>&#43; years of experience in complaint handling or customer quality.</span></span></span><span> </span></h3></li></ul></div></div><h3></h3><div><h3><b>Preferred-</b></h3><div><ul><li><h3><span><span>​</span><span><span>ISO 13485:2016<span> </span></span><span>certification</span></span><span>​</span></span><span> </span></h3></li><li><h3><span><span><span>Strong analytical and problem-solving skills; </span></span></span><span><span>​e</span><span><span>xcellent written and verbal communication skills and p</span></span></span><span><span><span>roficiency</span><span><span> </span>in QMS software and tools</span><span>.</span></span></span></h3></li><li><h3><span><span>Able to<span> </span></span><span>run<span> </span></span><span>communicate effectively</span><span><span> </span>with senior leadership</span><span>.</span></span><span> </span></h3></li><li><h3><span><span>Excellent<span> </span></span><span>problem-solving</span><span><span> </span>skills.</span></span><span> </span></h3></li><li><h3><span><span>Proactive to support both internal and external<span> </span></span><span>customers.</span><span> </span></span></h3></li></ul></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: None<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>