Performs supervisory and administrative duties associated with product Lot Release personnel management. Coordinates the tasks and work plans of the product release inspections. Ensure that all quality control activities comply with applicable regulatory requirements. This list contains tasks that are typically associated with the job. Build and lead a team of quality inspectors to perform thorough inspections of final products before shipment. This team will also be responsible for reviewing Lot Release paperwork and data at a sub assembly and finished goods level. Lead the set up/ establishment of the Lot Release test lab in the Athenry facility Oversee day-to-day operations of our Lot Release lab Implement and manage in-process quality control procedures to monitor and evaluate production processes. Collaborate with production teams to identify and address quality issues in real time. Support in routine audit readiness activities including cconduct regular Gemba walk, inspections and audits to ensure compliance with quality standards. Maintain accurate and detailed records of in-process and outgoing quality control activities. Prepare and submit comprehensive quality reports to management, highlighting key performance indicators, trends, and areas for improvement. Participate in root cause analysis and corrective action initiatives. Provide training to production and quality control personnel on quality standards, procedures, and best practices. Foster a culture of continuous improvement and quality consciousness throughout the organization. Responsible for addressing people performance issues and conflict resolutions if they arise Ensure a culture within production where Safety and Quality are a priority Responsible for addressing people performance issues and conflict resolutions if they arise Ensure a culture within production where Safety and Quality are a priority Works with QA, Manufacturing, Engineering, Supply chain and other department personnel, as necessary, to support quality and business objectives. Minimum a Bachelor's degree with ≥ 5 years of medical device, pharmaceutical, or other regulated industry experience in a supervisory role.Strong understanding of quality management systems, regulations, and standards (e.g., ISO 13485). Experience with statistical tools and methods for quality control Experience with start-up & scale-up organizations an advantage Experience working in a Digital Factory Proficiency with Microsoft Office, ERP System Strong problem solving and data analysis skill. Excellent leadership and communication skills. Ability to work collaboratively across cross-functional teams. Ability to work hands-on in a fast-paced environment Detail-oriented with a focus on continuous improvement.
