Ambalavanan Kumaressane

Ambalavanan Kumaressane has a diverse work experience spanning multiple companies and roles.

Starting in 2007, they worked as a System Administrator at Net Comp IT Solutions, where they gained certifications as a CCNA network administrator and MCSA system administrator. During this time, they were responsible for setting up and installing LAN and other networks, as well as debugging desktops and LANs.

In 2009, they joined Appasamy Ocular Devices as a Quality System Engineer. Here, they composed Technical Construction Files (TCF) for 26 products and achieved CE certification. Ambalavanan also worked on new product introductions (NPIs) related to Keratometry, Phaco emulsifier, and Yag laser, preparing technical files and export documents.

In 2011, they became a Senior RA/QA Engineer at Opto Circuits India Ltd. Ambalavanan supported the design control phase for several medical devices, including patient monitors, PADs, defibrillators, and treadmills. Ambalavanan also had responsibilities such as creating quality manuals, leading V&V teams, and ensuring proper design transfer.

Moving to HCL Technologies in 2014 as a Technical Lead RA/QA, Ambalavanan played a key role in the successful design and design transfer of insulin pumps and hemodialysis NPIs. Ambalavanan identified regulatory requirements for NPIs, provided extensive training for the team, and was awarded HCL live wire. In addition, they were responsible for regulatory standards identification and compliance for NPI product designs, risk management, software compliance, and gap analysis.

From 2017 to 2018, Ambalavanan worked at Sanmina, first as a Design Quality Lead and then as a Quality Management Representative. As a QA & RA Lead, they were accountable for design controls and served as an Agile Change Analyst for NPIs. Ambalavanan also handled risk management, CAPA compliance, and audits from notified bodies and customers.

Starting in 2018, they worked as a Technical Advisor - RA/QA at Meditix Solutions Private Limited, where they offered freelance services to start-up companies. Ambalavanan assisted companies in achieving compliance with QMS, QSR, MDD, and MDR, supported audit reviews, and facilitated CE marking for various medical devices.

From 2020 to 2022, Ambalavanan held the position of Design Quality Assurance Lead at GE Healthcare. In this role, they ensured QMS compliance in the design of tubes, tanks, and X-ray generators. Ambalavanan also handled MDR submissions and was a certified Six Sigma Green Belt professional.

Currently, Ambalavanan holds the role of Manager-Engineering Quality & Regulatory at LifeSignals Group, starting in 2022.

Overall, Ambalavanan has demonstrated extensive experience in quality assurance, regulatory affairs, design control, risk management, and compliance across various industries, including healthcare and medical devices.

Ambalavanan Kumaressane obtained their Bachelor's degree in Electrical, Electronics and Communications Engineering from Rajiv Gandhi College of Engineering and Technology, where they studied from 2004 to 2007. Prior to that, from 2002 to 2004, they attended Swamy Abedhanandha Polytechnic College, where they received a Diploma of Education in Electronics and Communications Engineering. Additionally, Ambalavanan has obtained several certifications in various fields from institutions such as Cisco, TÜV SüD, GE Healthcare, Microsoft, and HCL Technologies.