Quality Engineer – CAPA

Dallas, IA - USA

Monthly Salary: Not Disclosed

Posted on: 10-11-2025

Vacancies: 1 Vacancy

Job Summary

Position: Quality Engineer CAPA
Location: Dallas TX
Duration: Long Term

Overview:
Seeking an experienced Quality Engineer to lead the CAPA program and drive continuous improvement initiatives across the organization. This role ensures compliance with FDA ISO and other regulatory standards while supporting root cause investigations and quality system enhancements.

Key Responsibilities:

Own and manage the full CAPA lifecycle from initiation to closure.
Lead root cause investigations using 5 Whys Fishbone 8D and FMEA.
Collaborate with cross-functional teams (Engineering Manufacturing Regulatory Operations) to develop effective corrective and preventive actions.
Track CAPA metrics monitor effectiveness and identify improvement opportunities.
Maintain compliant documentation per ISO 13485 FDA 21 CFR Part 820 and related standards.
Support audits and train personnel on CAPA processes and quality procedures.
Contribute to continuous improvement and QMS optimization initiatives.

Qualifications:

Bachelors in Engineering Life Sciences or related field.
5 years in Quality Engineering within regulated industries (medical device/pharma).
Hands-on CAPA and RCA experience.
Knowledge of FDA QSR ISO 13485 ISO 14971 EU MDR.
Experience with eQMS (e.g. TrackWise).
Strong communication and project management skills.
CQE or Six Sigma certification preferred.

Position: Quality Engineer CAPA Location: Dallas TX Duration: Long Term Overview: Seeking an experienced Quality Engineer to lead the CAPA program and drive continuous improvement initiatives across the organization. This role ensures compliance with FDA ISO and other regulatory standards whil...