Senior CAPA Engineer

Position Overview

The Senior CAPA Engineer is responsible for strategic leadership, execution, and continuous improvement of the Corrective and Preventive Action (CAPA) system. This role ensures compliance with FDA 21 CFR 820, ISO 13485, and internal quality system requirements. The Senior CAPA Engineer leads complex investigations, mentors quality personnel, and drives systemic improvements across products, processes, and quality systems to ensure sustained compliance and product safety.

• Serve as system owner for the CAPA process in compliance with FDA 21 CFR 820.100 and ISO 13485:2016 Clause 8.5.2 and 8.5.3.
• Lead and approve complex CAPA investigations including audit findings, nonconformances, complaints, and process failures.
• Ensure appropriate root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
• Develop, implement, and monitor corrective and preventive actions that address both immediate and systemic issues.
• Define, execute, and document CAPA effectiveness checks to confirm long-term resolution.
• Ensure timely CAPA progression, documentation integrity, and compliance within the Quality Management System (QMS).
• Analyze quality metrics and trends to identify recurring and potential systemic issues.
• Link CAPA activities with risk management, complaint handling, audit outcomes, and management review.
• Provide subject matter expertise during FDA, Notified Body, and customer audits, including CAPA responses and follow-up.
• Mentor and coach Quality Engineers and cross-functional teams on CAPA and problem-solving best practices.
• Drive continuous improvement initiatives aligned with Lean and Six Sigma methodologies.
• Participate on cross-functional teams and represent the Quality function as a senior contributor.

• Bachelor’s degree in Engineering, Science, or related field
• 7+ years of experience in Quality Engineering within an FDA- and ISO-regulated environment
• Expert knowledge of FDA QSR (21 CFR 820) and ISO 13485 requirements
  Advanced root cause analysis and risk-based decision‑making
• Demonstrated experience leading CAPA systems and regulatory audit engagements

• Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA)
• Certified Project Management

• Light physical demands
• 5–10% travel