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.