Quality Manager Role
We are seeking a Quality Manager to join our team at our plastics contract manufacturing facility in Wicklow. This is a customer-facing role that requires strong knowledge of quality management systems and experience working with medical device clients in the US.
Responsibilities:
* Manage and develop quality assurance systems as an adjunct to production-led quality control for internal and external manufacturing.
* Ensure robust systems are in place to maintain compliance with customer specifications, the quality management system, and best practice.
* Develop and maintain quality standards for the business in line with ISO certification and best practice.
* Formalize and document all quality training and standards, provide and supervise all quality-related training, and drive strict adherence to these quality standards.
* Implement and execute inspection, testing, and evaluation methods to ensure that products and materials adhere fully to these standards.
* Maintain an effective internal auditing system per the QMS requirements.
* Develop and regularly report to relevant KPIs to confirm adherence.
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, ISO, and cGMP.
* Experience 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 the wider team.