Quality Systems Lead – Compliance & CAPA Excellence

Hardware FYI; El Paso, Northern (TX, KY); Ibrido; USD 105.000 - 125.000; Tempo pieno

Descrizione del lavoro

BD in El Paso, Texas is seeking a senior Quality Systems lead to direct and improve the QMS across multiple processes. The role includes guiding QA staff, coordinating CAPA activities, and driving compliance with FDA, GMP and ISO standards.

Ideal candidates have 5–8 years in regulated environments and a strong ability to interpret regulatory requirements into practical business solutions. On-site presence is required, with a focus on continual improvement and audit readiness.

Competenze

• Advanced knowledge of Quality Management Systems and applicable regulations.
• Experience with CAPA, Change Control, Training, Audit, Complaints and Document Control.
• Ability to translate regulatory requirements into practical business solutions.
• Experience supporting regulatory inspections and audits.

Mansioni

• Serve as the technical lead for assigned Quality System processes.
• Provide day-to-day guidance to Quality Systems personnel.
• Lead projects focused on compliance improvements and process optimization.
• Support CAPA activities including investigation, root cause analysis and effectiveness verification.
• Prepare quality system metrics, dashboards, and performance reports.
• Participate in regulatory inspections and customer audits.

Conoscenze

Quality Systems

CAPA

Change Control

Audit

Document Control

Root Cause Analysis

Project Management

Bilingual English/Spanish

Formazione

Bachelor's Degree

Descrizione del lavoro

BD in El Paso, Texas is seeking a senior Quality Systems lead to direct and improve the QMS across multiple processes. The role includes guiding QA staff, coordinating CAPA activities, and driving compliance with FDA, GMP and ISO standards.

Ideal candidates have 5–8 years in regulated environments and a strong ability to interpret regulatory requirements into practical business solutions. On-site presence is required, with a focus on continual improvement and audit readiness.