Position Summary

The Senior Quality Systems Engineer – CAPA & Continuous Improvement serves as a subject matter expert (SME) for Quality Systems with primary responsibility for the Corrective and Preventive Action (CAPA) process. This role is responsible for driving CAPA effectiveness, improving quality system performance, and ensuring compliance with applicable regulatory requirements and company standards.

The successful candidate will provide technical guidance, coaching, analytics, and continuous improvement support across the organization while partnering with cross-functional teams to ensure quality issues are effectively investigated, corrective actions are implemented, and quality system processes continue to improve. This position also serves as a key resource for Quality Systems requirements, root cause analysis, compliance initiatives, and quality performance reporting.

Key Responsibilities

CAPA Leadership & Quality Systems

• Serve as the Subject Matter Expert (SME) for CAPA processes across the organization.
• Provide guidance and coaching on investigations, root cause analysis methodologies, corrective actions, CAPA documentation, and effectiveness verification activities.
• Monitor CAPA performance and ensure corrective action plans are completed accurately, effectively, and on time.
• Analyze process nonconformances and support the development and implementation of corrective and preventive actions.
• Provide leadership and support for the timely communication and escalation of significant CAPA-related issues to Quality Leadership and Business Unit leaders.
• Collaborate with Post Market Quality to ensure timely completion of nonconformance escalation activities and Situation Analysis reviews.
• Apply Quality Systems principles including CAPA, document control, and related quality processes to support business objectives.
• Provide work