Tricia Richards

Customer-focused and detail-oriented Quality Professional with over 25 years in the medical device industry, including 12 years of Quality and Regulatory experience. Proven expertise in supplier quality management, CAPA, Supplier and Contract manufacturer ISO13485 auditing, and regulatory compliance (ISO 13485, FDA 21 CFR Part 820). Demonstrated ability to lead supplier qualifications, risk assessments, and process improvements that ensure device reliability and compliance.

Recognized for building strong supplier partnerships, driving continuous improvement and mentoring. Skilled in cross-functional collaboration to achieve excellence in performance, documentation control, known for accuracy, accountability and solution focused decision making in fast-paced environments.

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.