Site Quality Manager required for a leading healthcare organisation in Waterford. You will be joining a rapidly growing and dynamic organisation. The Quality Manager leads and directs all Quality activities of the site Quality organisation ensuring applicable regulatory and quality standards are adopted.
Overview of Main Responsibilities
- Lead and coordinate the strategic and tactical activities of the Quality Team to meet targets for customer delivery, product quality & ensuring a safe work environment at all times.
- Leads the use of lean tools to drive continuous improvement.
- Responsible for ensuring that their team is trained in their roles & also to support the development of standard work, documentation, training & work instruction activities where appropriate.
- Creates a high performing flexible team which achieves excellent results through coaching/mentoring & effective performance management.
- Manages the development, modification and maintenance of all quality evaluation and control systems in areas of product responsibility, and in compliance with company policies, customer requirements and government regulations ISO13485 & ISO9001: 2008 and EU GMP Volume 4 plus Annexes.
- Manages and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of raw materials, WIP and finished products and production equipment.
- Manages statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Manages the auditing process of quality systems for deficiency identification and correction and ensures that corrective action plans are put in place and executed in a timely manner.
- Manages the development of sustainable, repeatable and quantifiable business process improvements. Reports to management as necessary and required on the status of quality assurance programmes and practices.
- Ensure ongoing compliance with GMP in all practices, recording of events, and processes.
What the ideal Quality Manager looks like:
- Level 7 or 8 HETAC Science/Engineering Qualification in relevant discipline desirable.
- Level 7 management/relevant supervisory management qualification desirable.
- 5 years plus supervisory/leadership experience in a senior quality role is essential.
- Qualifications & experience in Lean (Green Belt level) are desirable.
- Experience in medical device injection moulding & assembly operations desirable.
What you will get in return:
- Competitive Salary.
- Pension.
- Healthcare.
- Bonus.
For a confidential discussion and more information on the role, please contact Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108