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QUALITY MANAGER

Guychardson Destin

As Quality Manager at Archimedic, Guy leads the team in Quality System Management (QMS), ISO 13485 Certification, auditing, continuous improvement, and more.

 

Guy started his career as a Quality Assurance Engineer working in medical software. Within this role, Guy built expertise in software design requirements, traceability, and compliance with 21 CFR Part 820, 21 CFR Part 11, various ISO standards, and HIPPA regulations.

Guy grew into a Quality Engineer driving quality processes and best practices while closely collaborating with product development engineers in creating new medical devices. Through his career, Guy has developed expertise in risk management, 21 CFR 820 quality system regulations (QSR), and 93/42/EEC Medical Device Directive (MDD). He is also a trained internal auditor for Medical Device regulations including ISO 13485:2016, and ISO19011:2018.

Guy’s current role at Archimedic is Quality Manager, where he maintains all aspects of the firm's quality management system (QMS) and ISO 13485 certification. In this role, Guy collaborates closely with the product development team to train, audit, and instill a mindset of continuous improvement. Additionally, Guy is an active contributor in project work from developing product requirements to conducting risk analyses, developing verification protocols, assembling comprehensive design history files (DHFs) and device master records (DMRs).

Guy lives outside of Boston with his family. During his non-working time, he spends his time playing soccer and basketball, listening to music, and reading.

Guy holds a Bachelor of Science in Mechanical Engineering from Northeastern University.