Open to opportunities

Kendrea Mayes

@kendreamayes

Experienced clinical quality professional driving compliance, audit readiness, and continuous improvement in medical devices.

United States

Message

What I'm looking for

I seek a clinical quality role where I can lead audit readiness, CAPA and SOP improvements, collaborate cross‑functionally, and drive regulatory compliance and continuous quality improvement.

I am a clinical quality specialist with deep experience applying GCP, GLP, ALCOA, ISO standards, EU‑MDR/IVDR, and FDA regulations to strengthen quality systems across global medical device and clinical research environments. I have led CAPA investigations, root cause analyses, SOP development, regulatory submissions, and audit readiness while partnering with Clinical Affairs, Safety, PMS, and R&D to reduce risk and support product lifecycle management.

I have implemented and taught evidence‑based quality improvements, supported regulatory inspections, served as lead auditor for internal and CRO audits, and contributed to development of 100+ SOPs and templates. I am a trusted subject matter expert, proactive problem‑solver, and effective communicator who elevates organizational quality culture and operational excellence.

Experience

Work history, roles, and key accomplishments

Sr. Clinical Quality Specialist

Becton Dickinson and Company

Jun 2022 - Oct 2025 (3 years 4 months)

Led clinical quality and compliance activities across global programs, developing 100+ SOPs, strengthening audit readiness, and delivering trainings that improved regulatory alignment and reduced operational risk.

GCP GLP ISO 13485 Trackwise Regulatory Submissions Root Cause Analysis

Sr. Clinical Quality Associate

St. Jude Medical

Sep 2019 - Jun 2022 (2 years 9 months)

Managed CAPA investigations and clinical quality activities to ensure GCP and ISO 14155 compliance, supported EU‑MDR and GDPR implementation, and contributed to audit preparedness and CAPA execution.

CAPA GCP ISO 14155 EU MDR GDPR Root Cause Analysis Cross Functional Collaboration

Post Market Surveillance Analyst

St. Jude Medical

Apr 2015 - Sep 2019 (4 years 5 months)

Coordinated MDR reporting and complaint handling for neurostimulation devices, led investigations and testing coordination, and executed CAPAs and trend analyses to improve product safety and compliance.

MDR Complaint Handling CAPA SAP Technical Reporting Trend Analysis Regulatory Submissions

Education

Degrees, certifications, and relevant coursework

Sam Houston State University

Bachelor of Science, Biology

Bachelor of Science in Biology with a minor in Chemistry; completed coursework in microbiology, organic chemistry, genetics, biochemistry, and related biological sciences.