Imelda Gunawan

Imelda Gunawan is an experienced quality management professional with a strong background in the medical device and laboratory sectors. Currently serving as the Quality Manager - Clinical at Trajan Scientific and Medical, Imelda maintains compliance with ISO 13485 and ISO 15189 standards while providing quality leadership for new product introduction projects. Previous roles include positions as QA Device Coordinator at Pfizer and Quality Assurance Manager at Defries Industries Pty Ltd, where responsibilities encompassed managing quality systems, leading teams for technology transfers, and ensuring regulatory compliance. With a career beginning as a Process Engineer at Silicon Manufacturing Partners Pte Ltd, Imelda has continually enhanced quality processes and systems across various organizations. Educational qualifications include a Bachelor of Engineering (Chemical) from the University of Melbourne and a Master of Science in Environmental Engineering from the National University of Singapore.