Amanda Amell
Quality Assurance Associate @Shoebox Ltd
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WORK HISTORY
Quality Assurance Associate @Shoebox Ltd
CA
EDUCATION
University of Ottawa
Bachelor of Arts (B.A.)
SKILLS
ABOUT AMANDA AMELL
Experienced Quality, Safety & Risk Associate in GMP Regulatory Affairs, ISO 9001:2015, ISO 13485:2016 Quality Management Systems, ISO 27001:2022 (ISMS), with a demonstrated history of working in the medical devices (including software) and pharmaceuticals industry. Customer Service driven. Skilled in Product Recalls & Complaints, Data Analysis, Policy Analysis and Development of Organizational Processes, Internal Audits, Microsoft Dynamics GP, Zoho One, Jira, Confluence, Scilife eQMS, etc. Skilled in Writing, Proofreading, and Editing. Experienced Trainer and preparer of Training Modules for various topics in relation to policies and procedures, regulatory compliance (GMP/DEL, MDEL, CMDR, CDSA, MDD/MDR, TGA, FDA, ANVISA) corrective actions, and health & safety awareness. Extensive knowledge of a variety of International Standards relating to Quality & Information Systems Management, Medical Device Software Design & Development, Auditing, Audiometry, Risk Management, etc.
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