Quality Systems Engineer – CAPA and Process Improvement

Drive quality excellence by owning the end-to-end CAPA process, from intake and triage through investigation, root cause analysis, corrective/preventive actions, and effectiveness verification. Facilitate CAPA review meetings, ensure documentation and traceability meet FDA 21 CFR Part 820 and ISO 13485 expectations, and maintain audit readiness through internal and external audit support. Track CAPA trends, improve QMS systems, and develop SOPs and change controls while mentoring teams on best practices.