Quality Operations Manager

1 day ago


Dublin, Ireland ICDS Group Full time

Quality Operations Manager - South Dublin. In this critical leadership role, you will be at the heart of the mission to maintain the highest standards of quality, compliance, and continuous improvement. Key Responsibilities: Quality Leadership: Be a key member of the Quality Leadership Team and the sites extended leadership team, ensuring quality systems align with ISO standards and regulatory requirements. Team Management: Lead, inspire, and develop the Quality Engineering Team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting. Continuous Improvement: Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies. System Oversight: Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis. Quality Control: Oversee the activities of the Quality Control group, ensuring seamless integration and high performance. Drive Change: Lead key improvements in quality assurance and control systems, championing innovation and operational excellence. Collaborate Externally: Build strong relationships with external customers, ensuring their needs and expectations are met. Regulatory Excellence: Ensure timely and compliant completion of CAPA's, maintain high-quality documentation, and prepare for audits with confidence. GMP Compliance: Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities. Education and Experience Requirements: A third-level qualification in Engineering or a Science discipline is required; a post-graduate qualification in a related area is a plus At least 5 years' experience in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry. At least 3 years' supervisory experience, with a proven track record of team development. Experience preparing technical documentation and managing CAPA systems. Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus). Knowledge of FDA requirements and experience managing FDA audits. Experience with process validation, sterilization, and cleanroom environments is advantageous. Strong interpersonal and communication abilities. Exceptional problem-solving and analytical skills. High-level computer literacy and the ability to work effectively in cross-functional teams. Skills: quality manager quality assurance quality control



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