Soumya Rajesh

Soumya Rajesh has over 17 years of work experience in various roles in quality assurance and regulatory affairs. Soumya is currently working as a QA/RA Manager at Cassini Technologies B.V. where they are responsible for managing quality assurance and regulatory affairs processes.

Prior to their current role, Soumya worked at Enraf-Nonius as a Manager - Product Manuals from 2016 to 2018. In this role, they were in charge of medical device registration and certification processes in EU/Non-EU countries. Soumya also advised on maintenance of the quality system and ensured compliance of product manuals and labeling with Medical Device Directives.

Before joining Enraf-Nonius, Soumya worked at Philips from 2015 to 2016. Soumya held the role of Document and Change Control Expert where they established document and record support and managed the documents review process. Soumya also served as a Document Control Specialist during their time at Philips.

From 2007 to 2011, Soumya worked at Jabil as a Quality&Continuous Improvement Engineer. Soumya was the central point of contact for all external and internal audit functions and directed and coordinated activities of the Document Control Department.

Earlier in their career, Soumya worked at Jabil Global Services B.V as a QMS Technician, and at Accel Frontline limited and Accel Frontline Ltd in roles such as Technical Support Engineer, Assistant Internal Auditor ISO 9001-2000, and Engineer-Quality Control.

Overall, Soumya Rajesh has a strong background in quality assurance, regulatory affairs, document control, and continuous improvement in various industries including medical devices and technology.

Soumya Rajesh completed a Bachelor of Engineering degree in Electronics & Communication from the University of Madras between 1997 and 2001. In 2001, they also obtained a degree in ACCEL Certified Computer Hardware & Network Engineering from Accel Academy, with a specialization in hardware and networking.

In addition to their formal education, Soumya Rajesh has acquired several certifications. In 2009, they obtained a LEAD AUDITOR ISO9001 certification from IRCA/DNV. In 2019, they became a member of the Regulatory Affairs Certification Program (RAPS). Most recently, in May 2020, they completed the Operational Excellence Work-Out and Kaizen Facilitator certification from LinkedIn.