Our client is a leading medical device company and is seeking an experienced CAPA Program Lead to lead a high-priority quality remediation initiative supporting medical device regulatory compliance. 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.
Numbers & Facts
Location
Somerset, NJ
Skills
Biologyunmatched
Cardiovascularunmatched
Communication Skillsunmatched
Consultingunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Documentationunmatched
Healthcare Qualityunmatched
Healthcare Softwareunmatched
Leadershipunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Process Analysisunmatched
Process Improvementunmatched
Project Trackingunmatched
Project/Program Managementunmatched
Purchasing/Procurementunmatched
Quality Assuranceunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Vendor/Supplier Quality Managementunmatched
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