Quality Manager - Galway, Ireland (On-site)
A global leader in medical technology is expanding their Quality Assurance team. They have an exciting new role for a Quality Manager in their Galway, Ireland location.
Job Overview
As Quality Manager, you will be responsible for ensuring that standards of quality are consistently being met, developing and implementing QMS, quality plans, programs and procedures by means of control statistics, Six sigma and manufacturing concepts. The Quality Manager will ensure that any quality discrepancies are reviewed and analysed and solutions are put in place and executed.
As Quality Manager you will be reporting to the Quality Director.
Responsibilities:
- Health and Safety - focus in line with plant objectives to ensure initiatives are successful and agreed targets are achieved.
- Works with the business unit and Engineering Manager to achieve the cascaded Plant objectives.
- Ensure QMS compliance, CAPA management, develop Quality operation strategy and drive continuous improvement
- Participate in new product introductions to ensure quality is built into all products early in their life cycle.
- Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
- Management and continued employee development of Quality staff.
- Develop and implement Manufacturing procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: Delivery of raw materials and components, Manufactured devices and equipment and Documentation associated with these functions.
Experience/requirements
- Relevant technical degree
- 7+ years relevant Quality Operations experience in GMP environment
- Strong people management experience.
- Hands on audit experience
- Experience with ISO13485, CFR 820, MDD/MDR
If you are interested in the position listed please apply or reach out directly
