Operations Excellence Manager
Accelerate innovation and drive quality excellence in a dynamic environment.
Job Overview
In this key role, you will lead critical projects for new product introduction, providing leadership to the Quality Engineering team and managing validation studies with various stakeholders. You will be responsible for ensuring quality systems align with ISO standards and regulatory requirements.
Responsibilities
* Lead the Quality Leadership Team to ensure quality systems are aligned with ISO standards and regulatory requirements.
* Develop and inspire the Quality Engineering Team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting.
* 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 key 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 CAPAs, 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 postgraduate qualification in a related area is advantageous.
* 5+ years in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.
* At least 3 years of 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 beneficial).
* Knowledge of FDA requirements and experience managing FDA audits.
* Experience with process validation, sterilization, and clean room environments is desirable.