Open to opportunities

Jalpa Patel

@jalpapatel2

I lead CAPA, post-market surveillance, and quality systems improvements across medical device and pharmaceutical organizations.

United States

Message

What I'm looking for

I'm looking to lead CAPA, post-market surveillance, quality systems, and data-driven compliance improvements in regulated medical device or pharmaceutical environments.

At W.L. Gore & Associates, I lead enterprise CAPA and nonconformance activities, compile multi-source quality data into executive dashboards, and deliver risk-based recommendations that improve product and process performance. Previously at BD, I generated KPI reporting, analyzed complaint, CAPA, and nonconformance trends, and supported global post-market surveillance activities.

Across Getinge, G&W Laboratories, Amneal, Hitachi Chemical, and Zydus Cadila, I've investigated product failures, facilitated corrective actions, supported vigilance reporting, and strengthened audit readiness under FDA, ISO 13485, MDR, and cGMP requirements. I also led Kaizen improvements that reduced batch review time by 30% and compliance issues by 40%.

Experience

Work history, roles, and key accomplishments

Current

Product Quality Manager

Current

W.L. Gore & Associates, Inc.

Dec 2024 - Present (1 year 9 months)

Led enterprise-level CAPA and nonconformance activities, including periodic reviews of open records to ensure timely closure and global compliance. Prepared executive-quality review materials by compiling multi-source datasets, developing dashboards, and delivering trend insights to leadership.