Tricia Richards

Strong written and verbal communication Skills ● Ability to work in groups & collaborate - Strong interpersonal communication skills ● Ability to work independently, managing work priorities ● Supplier Quality & Performance Management - Perform and maintain Qualification and yearly re-qualification for supplier accounts including ISO Certifications. ● Quality control processes ● Manufacturing standard operating procedures ● Maintain quality documentation and records in compliance with Good Manufacturing Practices (GMP) and good documentation practices. (GDP) ● Root Cause Analysis & CAPA Implementation utilizing 8D, 5 whys ● Comprehensive knowledge of Industry Regulations such as 21 CFR Part 211, 820 and ISO Standards: ISO 13485 / MDSAP / EU MDR / UKCA ● Internal, Supplier & Sub-supplier Auditing ● NPI – New Product Introduction & Prototype Support ● Gap Assessments ● Risk Management (ISO 14971) ● Device History Record (DHR) Review ● Nonconformance (NCR/MRB) & SCAR Management ● Process Validation & Change Control ● Quality Metrics, KPIs & Continuous Improvement ● Cross-Functional Collaboration with Contract Manufacturing, Operations, Hardware & Design Engineering, Logistics, Design Quality and Regulatory teams.

• ISO 13485 Certified Lead Auditor – May 2017 • ISO 14971 Risk Management Certified – Feb 2019 • Six Sigma Yellow Belt – Feb 2018 • IPC-A-610 Rev F Certified – Acceptability of Electronic Assemblies • GMP & 21 CFR Part 820 Proficiency • Regulatory Affairs Professionals Society (RAPS) – Regulatory Affairs Certificate: Medical devices Including certificates in: ▪ Introduction to Regulatory Affairs in the EU ▪ Medical Devices – Definition and Lifecycle ▪ Role of Regulatory Professional ▪ Post Market Surveillance - Currently studying this course online.