Quality Operations Manager
Key Responsibilities:
1. Lead the Quality Leadership Team and site leadership team to ensure quality systems meet ISO standards and regulatory requirements.
2. Develop, inspire, and lead the Quality Engineering Team through regular reviews and goal-setting, fostering collaboration and performance excellence.
3. Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies, improving processes and reducing waste.
4. Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis, ensuring effective resolution and continuous improvement.
5. Oversee Quality Control group activities, ensuring seamless integration and high performance.
6. Drive key improvements in quality assurance and control systems, championing innovation and operational excellence.
7. BUILD STRONG RELATIONSHIPS WITH EXTERNAL CUSTOMERS, ENSURING THEIR NEEDS AND EXPECTATIONS ARE MET.
8. Ensure timely and compliant completion of CAPAs, maintain high-quality documentation, and prepare for audits with confidence.
9. 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 desirable.
2. At least 5 years' experience in an ISO 9001/2000 or ISO 13485 environment, preferably in Medical Devices or 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 advantageous).
6. Knowledge of FDA requirements and experience managing FDA audits.
7. Experience with process validation, sterilization, and cleanroom environments is beneficial.
8. Strong interpersonal and communication abilities.
9. Exceptional problem-solving and analytical skills.
10. High-level computer literacy and ability to work effectively in cross-functional teams.