NEW ROLE: Quality Manager required for plastics contract manufacturing facility in Wicklow. This is a customer-facing role working with medical device clients in the US, responsible for audits, managing QMS, and customer complaints. Knowledge of ISO and cGMP is essential.
Responsibilities:
1. Manage and develop quality assurance systems as an adjunct to production led quality control for internal and external manufacturing.
2. Ensure robust systems are in place to maintain compliance with customer specifications, the quality management system, and best practices.
3. Continue to develop and maintain quality standards for the business in line with ISO certification and best practices.
4. Formalize and document all quality training and standards, provide and supervise all quality related training, and drive strict adherence to these quality standards.
5. Implement and execute inspection, testing, and evaluation methods to ensure that products and materials adhere fully to these standards. Develop and regularly report to relevant KPIs to confirm adherence.
6. Maintain an effective internal auditing system per the QMS requirements.
7. Continue to develop and maintain root cause analysis and timely and appropriate permanent corrective action in any case of non-adherence to standards.
8. Roster all quality staff according to production plan requirements and sign off on and expedite fortnightly payroll data for quality personnel to payroll processor in a timely manner. Ensure the quality team is agile to manage changing customer requirements.
9. Drive a continuous improvement ethos within the Quality department.
10. Recruit all staff for quality positions with the assistance and involvement of HR.
11. Implement and maintain a performance review process for all direct reports to include performance appraisal, retention, and training. Identify any skill gaps and implement training to bridge such gaps.
12. Liaise effectively and continuously with all other departments to effectively communicate the required quality standards and ensure strict adherence to these standards.
13. Liaise directly with customers as a primary point of contact in QA.
14. Lead investigation of customer complaints, implementing corrective and preventative actions in a timely manner and align with customer requirements.
15. Provide oversight of external manufacturing by implementing and maintaining effective supplier quality measures.
Requirements:
* Minimum 5 years of Quality management experience with evidence of building strong relationships.
* Evidence of working knowledge of Lean / Continuous improvement / WCM.
* Evidence of working knowledge of ISO and cGMP.
* Experienced in QMS auditing to ISO or supporting on-site customer audits.
* In-depth knowledge of process validation.
* Strong attention to detail.
* Strong organizational skills.
* Ability to communicate complex quality-related matters to a wider team.
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