Quality Engineer - Medical Device Production in Kildare
Cpl is supporting our client partner, a global leader in outsourcing contract manufacturing for medical device and sterile injectable products.
About the Role
* Support the ongoing development of the Quality Engineering function through the introduction of new world-class techniques and technologies.
* Liaise with Automated Production & Engineering to ensure goals, targets, and objectives are continuously met.
* Represent the company on quality issues and provide expertise and support to all aspects of operations.
Main Responsibilities
1. Serve as a site Subject Matter Expert for investigating productivity issues, product, plant or material deviations, and liaising directly with external suppliers and stakeholders.
2. Support production line areas for quality and material issues.
3. Collaborate with partners across the value chain for process, quality, and cost improvements projects.
4. Take a leadership role in internal audits and reviews of manufacturing operations and quality systems to ensure compliance with GMP and other regulations.
5. Develop the Quality Engineering function through the identification and introduction of new world-class techniques and technologies.
6. Work as part of the quality team to introduce new technology/techniques, develop skills, train processes, optimise, and save costs.
7. Provide specialist quality and technical engineering support to all departments.
8. Maintain, manage, and develop the Quality Management System.
9. Lead and participate in cross-functional teams and process improvement initiatives.
10. Develop the Quality Lab resource in line with product qualification and inspection demands.
11. Ensure validation and qualification of all new and existing products, equipment, and processes.
Additional Duties
1. Participate in the company's program to achieve and maintain an