Emily Deignan

Analytical and detail-oriented professional with hands-on experience in designing and optimizing quality assurance systems. Well-versed in implementing, reviewing, and maintaining ISO 13485/MDSAP QMS systems to ensure suitability, effectiveness, and compliance with applicable regulatory requirements. Possesses 2 years of experience leading a quality management team in an ISO 13485 environment and experienced in spearheading audits. Exceptional talent for overhauling QMS systems to implement risk-based approaches to quality management and product development lifecycle designs. Well versed in the selection and inspection of approved vendors, including conduction of vendor audits, interviewing potential vendors, and documentation trails for all externally sourced parts. Passionate about applying sound, systematic problem-solving methodologies to identify, prioritize, and resolve systemic quality issues. Skilled technical writer, adept at drafting variety of technical documents such as SOPs, master test plans, product specifications, system requirements, and human factors and usability analysis reports.

Cloud Dx Inc, Kitchener, ON 2021 – Present

Research Engineer

Redesigned QMS systems and acted as lead developer on data science projects within an ISO 13485 licensed environment, while serving as research and quality engineer. Performed interdisciplinary research, integrating data analytics with physiological vital metrics to recognize predictive trends and applied findings to design predictive algorithms for innovative medical equipment. Ensured on-time completion of project deliverables by managing QMS activities for team of seven colleagues. Drafted and maintained precise and up-to-date engineering documentation files for three emerging medical devices, including DHFs, DMRs, RMFs, and UEFs for each product. Recognized significant obstacles in QMS of three major products and optimized workflows to improve design process efficiency and facilitate seamless flow from research and development stages to product manufacturing and commercialization.

• Headed the research and development team in QMS and Regulatory Affairs, successfully navigating through several MDSAP, MDIT, and Health Canada audits with 100% pass rate and no major corrective actions.
• Formulated and executed a risk-based strategy for QMS product design/development that resulted in receiving high praise from external auditors and 100% adoption rate by all products in development stages.
• Enhanced design, development, verification, and validation processes of prototype test units for new concepts.

Doctor of Philosophy in Biomedical Engineering (Expected in early 2024)

University of Guelph, Guelph, ON

• Title: Translational Models of Biocompatibility: A novel approach to modelling the mechanical strength of median sternotomy adhesive solutions using Sheep models with a focus on the development and evaluation of novel biocompatible glass polyalkenoate cements for sternal closure.