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