Melissa Perri
Senior Quality Assurance Specialist @Alimentiv
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WORK HISTORY
Senior Quality Assurance Specialist @Alimentiv
EDUCATION
Western University
M.E.Sc., Electrical Engineering
McMaster University
B.Eng., Biomedical Engineering
SKILLS
ABOUT MELISSA PERRI
An experienced professional in regulatory, quality management systems (QMS), and clinical affairs with a demonstrated history of working in high-performance teams in the medical device and healthcare sector, such as with QA, R&D, CROs, and nursing teams in the hospital. Key areas of expertise are QMS planning, implementation and monitoring, including improving quality processes, policies, procedures, and developing training programs. Experience with implementing ISO 13485 and ISO 14971, leading internal quality audits and supplier audits, manage QMS certification and re-certification, and CAPA processes. Knowledge of medical device regulatory requirements for USA and Canada, regulatory submissions process, registration, and maintaining regulatory approvals in those countries, including post-market surveillance activities.
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