Review, plan, and coordinate the implementation of engineering and quality change controls.
Partner with Manufacturing Engineering teams to complete risk assessments, update work instructions, and develop FMEAs for product line extensions and process improvement initiatives.
Assess change controls for validation impact and ensure compliance with quality and regulatory requirements.
Apply statistical analysis techniques to support validation activities, process optimisation, and data-driven decision-making.
Collaborate with Manufacturing Engineering to develop validation strategies and sampling plans for both new and existing product lines.
Lead investigations into manufacturing and quality issues, driving effective problem-solving and resolution to maintain production efficiency.
Provide quality leadership, CAPA investigations, and product disposition activities.