Quality Operations Manager - South Dublin.

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 site’s 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.