Leadership of Line Transfers (Site-to-Site / Line Transfers)

Lead the planning, execution, and completion of manufacturing line transfers between plants (e.g., US → Mexicali), ensuring operational continuity and regulatory compliance.

Define and manage the Transfer Plan: scope, timeline, risks, resources, and success metrics.

Ensure the complete transfer of: Processes (manufacturing, inspection, testing)

Equipment and tooling Documentation (DHF/DHR, BOM, routers, work instructions)

Coordinate Run-at-Rate activities, pilot builds, and ramp-up until target production capacity is reached. Manage risks through FMEA and mitigation plans during the transfer.

Ensure compliance with quality standards during “dual production” or transitional phases.

Process Validation Management (IQ/OQ/PQ)

Lead the strategy and execution of process and equipment validations in accordance with ISO 13485, FDA 21 CFR Part 820, and corporate ...