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.
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