Job Title: Quality Engineer
We are seeking a highly skilled Quality Engineer to join our team in Longford/Roscommon. The ideal candidate will have prior medical device experience and a third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
About the Role:
* Develop and implement solutions to sustain and improve the QMS (Quality Management System).
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* Interface with customers on new products, quality issues, and process qualifications.
* Develop and implement process control programs to ensure customer requirements are met.
* Carry out process validations and qualifications on products.
* Provide manufacturing support and quality expertise in relation to manufacturing issues and product disposition.
* Perform quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
* Coordinate NCR / CAPA process to ensure timely resolution and closure of issues.
* Lead training activities on quality procedures, e.g., compliance, GMP, audit preparation, and GDP.
* Support and represent the site during external audits and carry out internal audits.
* Trend and track quality data to support quality improvements across the business.
* Support environmental, health, and safety requirements, training, and regulations.
Requirements:
* Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
* Experience in statistical analysis (Minitab), SPC, and validations.
* Excellent interpersonal, communication, influencing, and facilitation skills.
Salary Range:
€60,000 - €80,000 per annum.