Job Description

• Engineering change management for critical medical devices for the changes triggered by supplier change request, end of life, design transfer & compliance requirements.
• Led cross-functional teams including Regulatory Affairs, Labeling, Quality & Supply Chain, streamline change implementation and ensure compliance.
• Managed change control documentation, inventory coordination, and impact assessments for product labeling updates.
• Coordinated phased approach of project implementation, minimizing disruption to production and distribution channels.
• Reported regularly to senior leadership, providing operational insights, risk mitigation strategies, and escalation support.
• Orchestrate project feasibility, prioritization and execution of the project adhering to the QMS policies and completing the project on schedule, ensuring compliance with CFR 820, ISO 13485, and IEC 60601.
• Develop and communicate the risk management plan and update other stakeholders through four box update and project update presentations.
• Communication with external stakeholder's component suppliers and PCB manufacturers and ensure alignment of their quality processes for any change implemented.
• Ensure the change order is incorporated with tasks that enable seamless transition of the change from part number extension across plants to costing and sales status updates.
• Formalized testing to execute those components.
• Execute qualification tests.

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