Blessy Ponnachen
@blessyponnachen
Quality Engineer specializing in software validation and regulated QA for medical devices.
IndiaWhat I'm looking for
I’m a Quality Engineer and software validation professional with over 5.5 years of experience in the medical device industry, including 3 years and 3 months in Quality Engineering roles. I specialize in software validation, process improvement, and regulatory compliance, supporting CSV activities (IEC 62304) with strong documentation discipline.
I help teams maintain QMS alignment with ISO 13485 and execute risk management per ISO 14971, while managing CAPAs and NCs across SaMD, SiMD, and computer system validation projects. In my current/most recent role, I’ve authored SDLC deliverables (URS/FRS, risk assessments, test plans, reports) and validated ERP/non-product software tools (e.g., Epicor modules, Access Bio CareStart), partnering cross-functionally to drive continuous improvement in regulated environments.
Experience
Work history, roles, and key accomplishments
Associate Software Quality Engineer
Iziel Software Solutions
Apr 2023 - Mar 2025 (1 year 11 months)
Performed IEC 62304 gap analysis and authored SDLC quality deliverables for SaMD/SiMD projects, including URS, FRS, risk assessments, test plans, and verification reports. Validated ERP and non-product software tools using IQ/OQ/PQ and supported dry runs, revalidation, and version upgrades in regulated environments.
Quality Engineer
Muse Diagnostics Pvt. Ltd.
Dec 2021 - Apr 2023 (1 year 4 months)
Drafted, released, and maintained SOPs and departmental forms aligned to ISO 13485 QMS, and conducted ISO 13485/ISO 14971 training organization-wide. Managed CAPA and nonconformities, performed IQ/OQ/PQ process validations, and produced test reports with error tracking for device-related testing.
Sales Engineer
Texus Healthcare System Pvt. Ltd.
Apr 2021 - Sep 2021 (5 months)
Provided clinical and sales support across Kerala hospitals and clinics, including surgical assistance and medical device demonstrations. Promoted devices and supported product demos for medical staff to drive sales and adoption.
Sales Engineer
Eros Medical Systems
Nov 2019 - Mar 2020 (4 months)
Delivered in-theatre support and conducted medical device demos for hospitals in Kerala. Managed sales lifecycle activities including inquiries, quotations, and purchase orders.
Biomedical Trainee
Matha Medical Centre
Sep 2017 - Mar 2018 (6 months)
Supported biomedical engineering staff during mock NABH inspections and assisted with OR support for medical equipment. Helped with maintenance and calibration of critical biomedical equipment.
Biomedical Trainee
N.S. Memorial Institute of Medical Sciences
Aug 2016 - May 2017 (9 months)
Maintained biomedical inventory and service schedules, and supported device demos and troubleshooting in the OR. Assisted with on-site support for medical equipment and routine operational needs.
Education
Degrees, certifications, and relevant coursework
Annamalai University
Master of Business Administration (Hospital Management), Hospital Management
2018 - 2020
Completed an MBA in Hospital Management (D.D.E) at Annamalai University from 2018 to 2020.
PSNA College of Engineering and Technology
Bachelor of Engineering, Biomedical Engineering
2012 - 2016
Completed a B.E. in Biomedical Engineering at PSNA College of Engineering and Technology from 2012 to 2016.
Bethany Balika Madom HSS
Higher Secondary Education, Higher Secondary Education
2010 - 2012
Completed higher secondary education at Bethany Balika Madom HSS from 2010 to 2012.
Availability
Location
IndiaAuthorized to work in
Job categories
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