Job Specification – Quality Engineer
Location:
Cork, Ireland
Status:
Onsite
Role Type:
Quality Engineering
Purpose of the Role
This role sits within the Quality Team of a large medical device manufacturing facility.
The successful candidate will provide expert QA support to Operations, ensuring that the plant achieves its quality, output, and cost objectives.
Key Responsibilities
Operational & Quality Support
Provide effective and responsive QA support across Operations to ensure area objectives for quality, cost, and output are met.
Supervise and develop Quality Technicians.
Implement and drive process improvements to achieve predictable and efficient processes across all product lines (including risk reduction, yield improvements, error-proofing, automation initiatives, and cost reduction).
Process & Systems Excellence
Ensure all process variables and interactions are defined, and all failure modes are identified and addressed (e.g., DOE studies, FMEAs).
Drive improvements across the site's quality systems.
Implement appropriate statistical techniques for monitoring process performance (e.g., SPC, Cpk analysis, sampling approaches).
Approve product, process, and quality system change requests.
Regulatory & Compliance
Ensure compliance with cGMP requirements and all relevant medical device regulatory bodies.
Provide guidance to cross-functional teams on regulatory requirements, sampling principles, and statistical techniques.
Compile regulatory documentation, including technical files, design dossiers, product transfer files, and essential requirements documentation.
Validation & Technical Support
Define validation requirements for processes, products, and test methods.
Prepare and approve Master Validation Plans, validation protocols, and reports.
Support the transfer and implementation of products and processes from development or other manufacturing facilities.
Other Responsibilities
Analyse customer complaint returns, approve analysis reports, and track complaint trends.
Review MRB trends and drive appropriate corrective actions.
Perform internal quality audits.
Support Lean Manufacturing initiatives across the site.
Education & Experience
Bachelor's degree in Engineering or Technology (minimum).
2–3 years' experience in a manufacturing environment, ideally within QA (GMP-regulated environment preferred).
Experience in the medical device sector is an advantage.
Experience working on automated or high-volume production lines is desirable.
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