Quality Manager

Harry Walsh Associates Ltd

Clonmel, Tipperary

Quality Manager required by leading Medical Device manufacturer. This role will work cross functionally with Production and Engineering Managers to ensure that all products are manufactured to the highest standards and under the highest GMP / FDA conditions. Managing a team of over 20 with responsbility for Quality related activities for device manufacturing and participate in Site & Corporate initiatives. Responsibilities: o Makes decisions regarding work processes, operational plans and schedules in order to achieve department and site objectives. o Develops, monitors and appropriately adjusts the annual budget for the areas of operation. Participates with manufacturing management at all levels in problems relating to quality, compliance and reliability. Oversees the completion of the annual product review as requested. Establish and maintain effective structures to ensure consistent implementation of the quality system for Clonmel facility as the site of legal manufacture. Monitors compliance with company policies and procedures (for example (e.g.) compliance with Food and Drug Administration (FDA), International Standards Organisation (ISO), Equal Employment Opportunity (EEO) regulations and standards, etcetera (etc.) and escorts inspectors/auditors for third party and unannounced inspections/audits. Approves documents defining the quality system and can own documents. Coordinates where required audits by external bodies to the site and supports audits as requested across the division. Ensures where applicable that the internal audit schedule is executed in a timely and effective manner. Drives continuous improvement / Corrective Action Preventive Action (CAPA) and validation initiatives. Experience: Must have a Science / Eng Degree with minimum 9 years experience in a regulated manufacturing industry, 5+ year in a quality function. Proven people mangement experience. Medical device experience. Next Steps: Apply now by clicking the “Apply” button below. Not quite ready to apply, or have some questions first? Call Evelyn 021 436 8330 to discuss this role in confidence. “Finding the right job for you....your job your location and your salary!” This job originally appeared on RecruitIreland.com.

2325 days ago