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Job Description
Quality Engineer sought for a leading supplier of consumer goods in County Longford, responsible for ensuring compliance with ISO 13485 and ISO 14001 standards and developing strategies to maintain and improve the Quality Management System.
Job Description
The Quality Engineer will support all Quality aspects that impact the successful functioning of the manufacturing facility, reporting directly into the Quality Manager. This is a permanent, Monday – Friday position.
Key Responsibilities:
- Ensure compliance with ISO 13485 and ISO 14001 standards and develop strategies to maintain and improve the Quality Management System.
- Engage with customers on new products and quality concerns, while developing and implementing process control programs to meet their requirements.
- Manage process validations and product qualifications and provide quality expertise and manufacturing support for resolving production issues and product disposition.
- Conduct quality engineering analysis to prevent non-conformances to minimize risk and in turn coordinate the NCR/CAPA process for timely issue resolution and closure.
- Lead training on quality procedures such as compliance, GMP, and audit preparation, while supporting and representing the site during external and internal audits.
- Supporting Environmental, Health and Safety requirements, training, and regulations.
Requirements:
- Third level qualification in Engineering, Polymer Science, or equivalent.
- A minimum of 3 years' experience as a Quality Assurance Engineer in a medical manufacturing industry.
- Experience in injection moulding is essential.
- Knowledge of statistical analysis (Minitab) / SPC / validations.
- Experience in CMM/NPI is desired.