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NEW ROLE: Quality Manager required for a plastics contract manufacturing facility in Wicklow. Working with medical device clients in the US, this is a customer-facing role responsible for audits, managing QMS, and customer complaints. Knowledge of ISO, ISO, and cGMP is essential.
Responsibilities
1. Manage and develop quality assurance systems alongside production-led quality control for internal and external manufacturing.
2. Ensure systems are in place to maintain compliance with customer specifications, the quality management system, and best practices.
3. Develop and maintain quality standards in line with ISO certification and industry best practices.
4. Formalize and document all quality training and standards, provide supervision, and ensure strict adherence.
5. Implement inspection, testing, and evaluation methods to ensure product and material compliance, and report on KPIs.
6. Maintain an effective internal auditing system per QMS requirements.
7. Develop and maintain root cause analysis and implement timely corrective actions for non-conformances.
8. Schedule quality staff according to production plans, approve payroll data, and ensure team agility.
9. Drive continuous improvement within the Quality department.
10. Recruit quality personnel with HR support.
11. Implement performance review processes, identify skill gaps, and organize training.
12. Coordinate with other departments to communicate quality standards and ensure compliance.
13. Act as the primary QA contact with customers.
14. Lead investigations of customer complaints and implement corrective/preventive actions.
15. Oversee external manufacturing quality measures.
Requirements
* Minimum 5 years of quality management experience with proven relationship-building skills.
* Knowledge of Lean, Continuous Improvement, and WCM methodologies.
* Experience with ISO, ISO, and cGMP standards.
* Experience in QMS auditing and supporting customer audits.
* Deep understanding of process validation.
* Strong attention to detail and organizational skills.
* Ability to communicate complex quality issues effectively.
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