Responsible for Engineering Change Review, 8D Review, and coordination, interface with downstream as required, e.g., excursion-related, packaging feedback.
Act as the SQE audit lead for internal/ external audits (ISO9001/13485/GMP), ensuring compliance, audit readiness, and prompt implementation and closure of corrective actions.
Responsible for new supplier phase in assessment and qualification through first article inspection and audit, as well as support engineering sample buy-off in the event of safe launch, supplier PCN, and change management
Responsible for Engineering Change Review, 8D Review, and coordination, interface with downstream as required, e.g., excursion-related, packaging feedback.