About the Company
Our client is a leading multinational medical device company that specialises in innovative solutions to improve quality of life.
About the Position
We are seeking a Quality Operations Manager to join our team in a critical leadership role.
As a key member of the Quality Leadership Team and the site's extended leadership team, you will be responsible for ensuring our quality systems align with ISO standards and regulatory requirements.
Key Responsibilities:
* Quality Leadership: Be a key member of the Quality Leadership Team and the site's extended leadership team, ensuring our quality systems align with ISO standards and regulatory requirements.
* Team Management: Lead, inspire, and develop the Quality Engineering Team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting.
* 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 CAPAs, 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.
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 of supervisory experience with a proven track record of team development.
Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).
Knowledge of FDA requirements and experience managing FDA audits.
A competitive package is available including generous salary and benefits.