Job Description
Quality Assurance Lead at Embecta Embecta is a global diabetes care company leveraging its 100-year legacy in insulin delivery to empower people with diabetes. This role leads critical projects for new product introduction at Embecta Dun Laoghaire, providing leadership to the Quality Engineering team, managing validation studies, and collaborating with internal and external stakeholders. Key responsibilities include: * Supporting ISO9000/ISO13485 Quality Systems and ensuring regulatory compliance * Leading the Quality Engineering Team and overseeing systems related to production support * Liaising with external customers to meet quality standards * Ensuring Corrective and Preventive Actions (CAPAs) comply with regulatory standards * Overseeing Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities Requirements include: * At least 5 years in an ISO environment, preferably in the medical devices or pharmaceutical industry * A minimum of 3 years in a supervisory role, indicating the need for leadership skills * Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous * Advanced technical writing skills and experience with FDA requirements and audits * Experience in process validation, sterilization, and cleanroom environments is a plus Embecta is an Equal Opportunity/Affirmative Action Employer, valuing diversity and inclusivity in the workplace.