Quality Operations Manager
This is a critical leadership role at the heart of maintaining high standards of quality, compliance, and continuous improvement.
Key Responsibilities:
* Lead the Quality Leadership Team, ensuring quality systems align with ISO standards and regulatory requirements.
* Develop and manage the Quality Engineering Team, fostering collaboration, delegation, and performance excellence.
* Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
* Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
* Oversee the activities of the Quality Control group, ensuring seamless integration and high performance.
* Lead improvements in quality assurance and control systems, championing innovation and operational excellence.
* BUILD strong relationships with external customers, ensuring their needs and expectations are met.
* Ensure timely and compliant completion of CAPA's, maintain high-quality documentation, and prepare for audits with confidence.
* Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.
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.