Shweta Choudhary
@shwetachoudhary
I build audit-ready medical device quality systems and strengthen supplier quality, CAPA, and product-launch controls.
CanadaWhat I'm looking for
I've supported medical-device quality and product-lifecycle work at Boston Scientific, managing supplier controls, CAPA, change control, complaint investigations, and quality documentation within ISO 13485 and ISO 9001 environments.
At Greene Group Industries, I maintain an ISO 9001/13485-aligned QMS, lead nonconformance investigations, develop SOPs, PFMEAs, Control Plans, and FAIR packages, and analyze plant-wide quality metrics to drive corrective action. I independently completed a comprehensive internal audit in two weeks, identifying compliance gaps and accelerating follow-up actions.
I'm an ISO 13485:2016 Lead Auditor who works closely with Engineering, Operations, R&D, suppliers, and Quality teams to improve audit readiness, supplier performance, design transfer, early production, and risk-based quality decisions. I'm interested in applying this hands-on QMS experience to Digital Health and SaMD environments.
Experience
Work history, roles, and key accomplishments
Quality Engineer
Greene Group Industries
Aug 2025 - Present (1 year)
Support and maintain an ISO 9001/13485-aligned Quality Management System, ensuring procedures, records, product-quality activities, and customer requirements remain controlled and audit-ready. Conduct CAPA investigations independently and lead nonconformance investigations, driving root-cause analysis, corrective/preventive actions, documentation, and timely closure.
Supported medical-device quality and product-lifecycle activities within an ISO 13485/ISO 9001 regulated QMS, including complaint investigations, nonconformance resolution, CAPA, supplier controls, change control, and quality documentation. Issued and managed CAPA and Supplier Corrective Actions, guiding root-cause analysis, corrective-action implementation, effectiveness, and timely closure.
Education
Degrees, certifications, and relevant coursework
McMaster University
Master of Engineering, Manufacturing Engineering
Master of Engineering in Manufacturing Engineering from McMaster University, completed in April 2019.
DAV Institute of Engineering and Technology
Master of Technology, Electrical Engineering
2012 - 2015
Grade: 3.8
Activities and societies: a
Pursued a Master of Technology in Electrical Engineering at DAV Institute of Engineering and Technology, Jalandhar, Punjab, India.
Tech stack
Software and tools used professionally
Availability
Location
CanadaAuthorized to work in
Salary expectations
Social media
Job categories
Skills
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