Site Quality Manager

Posted 30 January 2020
SalaryUp to €1 per annum
Job type Permanent
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ContactShane Browne

Job description

This leading Medical Devices organisation has been a long time investor in Ireland with operations here since the 1960s. Employing in the region of 50,000 employees globally and revenues north of 10 billion per annum, this organisation remains one of the largest Medical Devices organisations globally. Since its introduction to Ireland, this innovator has proceeded to continuously invest in this country including investments in additional manufacturing and research sites across Ireland. One of the organisation's primary plants based in North Leinster is currently undergoing significant investment and change. They have transformed its operations in Ireland through strong leadership, continuous innovation and demonstrating the importance of this site to the organisation's global manufacturing operations. At present, a requirement exists for a Quality Leader to Head up all Quality responsibilities including team management for the site and sitting as part of the organisation's Site Leadership Team.

The Position:

  • Manage and implement Global Quality Objectives at the site level
  • Ensure that all devices manufactured meet required quality specifications, through moulding, assembly, packaging, sterilisation and release
  • Manage and develop the staff in the Quality department through involvement, delegation, and regular reviews of performance as established in IIGs
  • Drive Quality Improvement Plans at the site
  • Responsible for ensuring adherence to all organisations, external and appropriate regulatory requirements (e.g. ISO, FDA)
  • Manage quality metrics across the site and ensure adherence to site quality targets
  • Liaise on a worldwide basis with quality, engineering, R&D, marketing, and manufacturing staff
  • Member of the Site Leadership Team, with the responsibility to support key initiatives and development strategy for the site
  • Act as Management Representative with specific responsibility for the Quality System. Manage the Batch Release Process to meet Supply Chain Requirements Analyse customer complaints and modify processes/equipment/operator standards as necessary to eliminate defects
  • Implement and coordinate the CAPA process
  • Assign disposition to non-conforming materials
  • Manage quality spend budget and challenging spend where appropriate
  • Manage updates to the Quality Manual
  • Internal Quality Auditing Co-ordination
  • Communication with the Notified Body on Quality and Regulatory issues
  • Conduct Management Review sessions
  • Support Sales and Marketing Customer Centricity Objectives

The Person:

  • 10+ years' experience in a Quality environment within a Medical Devices/Pharmaceutical industry
  • Excellent knowledge of the ISO 13485 Quality Standard
  • A working knowledge of FDA requirements and managing FDA audits
  • Demonstrated ability to lead, direct and influence people
  • Excellent people management and communication skills
  • Strong planning and organisational ability

To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321865 for a confidential discussion.