Professional Summary

Medical Systems Engineer (M.Sc.) and Marketing Chair of ASQ Ottawa Valley Section, specializing in medical device R&D and global regulatory frameworks (CMDR, FDA, EU MDR). I have internship experience in EU R&D teams (Germany), applying Quality Management Systems (QMS) (ISO 13485), Risk Management (ISO 14971), and Verification & Validation for Class III (high-risk) devices, leading to market-ready products. Driven by my passion for healthcare technology and commitment to continuous improvement, I actively expand my proficiency in practical regulatory and quality techniques, tools, and standards to contribute to the safety and compliance of medical device lifecycles.

Technical Skills & Proficiencies

• Quality & Design Controls: Verification & Validation, Technical documentation, CAPA, RCA, FMEA
• Regulatory Compliance: CMDR (SOR/98-282), FDA 21 CFR, EU MDR 2017/745, ISO 13485, ISO 14971, ISO 9001, GxP
• Statistical Process Control Tools: Minitab, JMP, MS Excel
• Software & Engineering Tools: eQMS, MATLAB, SolidWorks, Python, MS Office Suite
• Soft Skills: Analytical problem-solving, Project management, Interdisciplinary Collaboration, Communication
• Languages: English (Advanced), French (Basic), German (Intermediate)