Summary:This consultant will assess existing quality processes, identify compliance gaps related to raw materials and components, develop and execute remediation plans, and partner with cross-functional teams to implement sustainable process improvements. This is an ideal opportunity for a seasoned medical device quality professional who combines deep CAPA expertise and regulatory knowledge with strong program management capabilities.
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.
- Ability 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.
