CAPA Program Lead

Roles & Responsibilities

• Lead a complex CAPA and quality remediation program, driving activities from assessment through implementation.
• Evaluate existing processes, documentation, supplier controls, and quality systems to identify compliance gaps and root causes.
• Develop and execute remediation plans, including project timelines, milestones, risk management, and cross-functional action plans.
• Partner with Quality, Regulatory, R&D, Manufacturing, Procurement, and global stakeholders to drive alignment and accountability.
• Facilitate recurring project meetings, monitor progress, manage risks, and provide executive-level status reporting.
• Support development and revision of quality system documentation, procedures, and training materials to ensure regulatory compliance.
• Drive implementation of corrective and preventive actions, including supplier quality improvements, process enhancements, and verification activities.
• Ensure remediation activities and supporting documentation are inspection- and audit-ready while establishing sustainable long-term processes.

Requirements

• BS degree in Life Sciences or related discipline.
• Extensive experience leading CAPA, regulatory remediation, or quality system improvement initiatives within the medical device industry.
• Strong knowledge of medical device Quality Management Systems, CAPA processes, root cause analysis, risk management, supplier quality, and quality documentation.
• Demonstrated program/project management experience leading complex, cross-functional initiatives across global organizations.
• Experience supporting supplier controls, raw material/component documentation, and regulated manufacturing environments.
• Excellent communication, facilitation, and stakeholder management skills.
• Able to work effectively across international teams and support meetings aligned with Japan time zones.
• Experience supporting Japan medical device regulatory requirements and quality documentation expectations.
• Experience with Class III and/or cardiovascular medical devices.
• Familiarity with global regulatory remediation programs and audit readiness.