Quality Operations Manager
Quality Operations Manager - Galway
Reporting to the Quality Director, the Quality Operations Manager will be responsible for maintaining and driving continuous improvement of the company’s product Quality and Compliance. The Quality Operations Manager will ensure a culture of continuous improvement is in place to drive improved compliance, effectiveness, and efficiency. You will be fully responsible for managing 5 direct reports (quality technician and engineer level
- Works with the business unit and Engineering Manager to achieve the cascaded Plant objectives.
- Develop Quality Operations Strategy for the business unit.
- Drive a Quality continuous improvement and innovation culture.
- Lead and support the Cost of Poor Quality initiatives.
- Develop strong links with customer organizations.
- Ensure compliance to the Quality Management system in all activities.
- 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 development of Quality staff.
- Promote awareness of the applicable regulatory requirements and Quality Management system requirements throughout the organisation.
- Develop and implement Manufacturing procedures and systems to assure product manufactured for human use meets design and functional specifications.
- Develop, track, and report on the following administrative systems
- Support regulatory agency and customer Quality audits. Act on behalf of Plant Management during audits.
- Ensure all aspects of the site QMS are managed and developed in line with regulatory standards, and ensure a culture of continuous improvement is in place to drive improved effectiveness and efficiency.
- Authority to place products or processes on hold.
- Level 8 degree in Science, Engineering or a related subject.
- 5+ years relevant Supplier Quality / Quality Operations experience in GMP Manufacturing environment in Medical Device/Pharma industry.
- Strong people management experience
A competitive package is on offer which includes;
· Annual bonus
· Full family healthcare
· Pension scheme
Please contact Elaine Dolan in Collins McNicholas, Galway for a confidential discussion;
091 706 718