Quality Operations Manager Role Summary
We are seeking an exceptional Quality Operations Manager to lead our quality initiatives and drive continuous improvement. This critical leadership role requires a proven track record of team development, quality management, and regulatory compliance.
Key Responsibilities:
* Quality Leadership: Collaborate with the Quality Leadership Team to align quality systems with ISO standards and regulatory requirements.
* Team Management: Lead, inspire, and develop the Quality Engineering Team, fostering collaboration, delegation, and performance excellence.
* 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.
* 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.
Skills: quality manager quality assurance quality control