Commercial Quality Manager Supplier Quality

Johnson & Johnson MedTech seeks a Commercial Quality Supplier Quality Manager to oversee supplier quality and lifecycle management for Abiomed's commercial operations. The role ensures externally provided products and services meet regulatory requirements and quality standards while supporting the medical device quality management system.

Responsibilities

• Manage supplier identification, risk classification, qualification, approval, and onboarding processes
• Apply risk-based controls for marketing materials, translation services, and commercial suppliers
• Lead supplier qualification activities including audits, assessments, and approval recommendations
• Monitor supplier performance using quality, delivery, and compliance metrics
• Support internal and external audits and regulatory inspections related to supplier controls

Requirements

• Experience managing supplier quality programs for medical device or regulated industries
• Knowledge of quality systems, risk-based controls, and regulatory compliance requirements
• Ability to conduct supplier audits, assessments, and due-diligence activities
• Experience with quality agreements, specifications, and purchase document controls
• Strong communication and stakeholder management skills across cross-functional teams
• Proficiency with quality management systems and supplier quality software platforms