Quality Engineer – CAPA , Dallas, TX.

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 :

Bachelor's 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.