· Develop, validate, qualify, and maintain test methods, electromechanical fixtures, jigs, test benches, and equipment, including IQ/OQ activities and measurement system assessments.
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.
Develop and lead continuous improvement by applying applicable problem-solving methodologies, such as fish-bone diagram, 8D, 5Why, or equivalent, on supplier quality processes, purchasing controls, and supplier performance monitoring systems to meet QARA requirements and business goals.
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.