Job Title: Quality Engineer Level 2

Location: Cork, Ireland

Purpose of the Role

The Quality Engineer will act as a key member of the Quality team, providing expert QA support to Operations to ensure the achievement of plant-wide quality, cost, and output objectives. The role involves driving process improvements, ensuring regulatory compliance, and maintaining robust quality systems across all product lines.

Key Responsibilities

• Drive and implement process improvements to ensure predictable, stable processes across all product lines, including initiatives in risk reduction, yield improvement, error proofing, complaint reduction, cost reduction, and process automation.

• Provide effective and responsive QA support to Operations, ensuring quality, cost, and output targets are met.

• Ensure all process variables, interactions, and potential failure modes are clearly defined and addressed using appropriate methods (e.g., DOE studies, FMEAs).

• Lead and implement plant-wide quality system improvements.

• Ensure compliance with cGMP and relevant medical device regulatory requirements.

• Provide expertise on quality-related issues, including regulatory standards, statistical techniques, and sampling methodologies.

• Apply appropriate statistical tools to monitor and improve process performance (e.g., SPC, CpK analysis, sampling techniques).

• Review and approve change requests for product, process, and quality system changes.

• Manage customer complaint handling, including analysis of returned product, approval of analysis reports, and assessment of complaint trends.

• Define validation requirements for processes, products, and test methods; prepare and approve master validation plans, protocols, and reports.

• Compile and maintain regulatory documentation such as technical files, product transfer files, design dossiers, and essential requirements documentation.

• Participate in MRB activities, reviewing trends and identifying corrective actions where necessary.

• Support and promote the implementation of Lean Manufacturing across the site.

• Support the transfer and implementation of new products and processes from development or other manufacturing facilities.

Education & Experience Requirements

• Minimum of a Bachelor’s Degree in Engineering or a related technical discipline.

• 3–4 years’ experience in a manufacturing environment, ideally with direct exposure to QA activities within a GMP-regulated setting.

• Experience within the medical device industry is advantageous.