Quality Manager

Job Overview

Senior Leadership opportunity for a Senior Quality Manager (Head of Quality) with expanding Life Sciences Client in South Dublin. Key appointment for the site which sits on the Global Leadership Team.

Permanent position, very attractive salary and competitive benefits package.

Key Responsibilities:

  • Work with the Site Leadership Team to ensure Quality Objectives are identified to meet the requirements of the product and monitored.
  • Manage and develop the staff in the Quality department through involvement, delegation, and regular reviews of performance
  • The Quality Manager is responsible for the management, direction and coordination of all quality and regulatory activities across the site. This includes providing the quality support to ensure that the required production, quality and regulatory standards are achieved across all areas of the business.
  • You will ensure that all devices manufactured meet required quality specifications. Leading the Quality functions across the site: Quality Management Systems, Quality Engineering, Microbiology, and Validation.  You will establish and lead the Quality Organisation for its responsibility and authority to implement and maintain an effective Quality Management System.
  • Establish, implement and maintain processes needed for the Quality Management System Quality Manual, applicable standards and regulation.
  • Analyse customer complaints and modify processes/equipment/operator standards as necessary to eliminate defects.
  • The Quality Manager will represent the company when interfacing with external parties such as Regulatory Agencies and Notified Bodies on matters relating to Quality Management System.  Become the contact person with IMB, NSAI, BSI, FDA and other Regulatory Bodies.

Requirements

  • Bachelor's Degree in an Engineering or Science Discipline
  • Minimum 10 years' experience in a Quality high volume manufacturing environment with at least 5 years at a senior management level within a Medical Devices/Pharmaceutical Industry
  • Minimum 5 years people management experience (managing managers)
  • Excellent knowledge of an ISO 13485 environment
  • Experience in the preparation of Technical Documentation 
  • Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous)
  • Experience in CAPA system management 
  • A working knowledge of FDA requirements and managing FDA audits
  • Demonstrated ability to lead, direct and influence people
  • Excellent interpersonal and communication skills
  • Strong planning and organizational ability

Next Steps:
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For more information on this role and to review the full details on this opportunity, please email or give me a call. I would be delighted to speak with you and guide you through the whole process!

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