Manufacturing Engineer Role
A challenging opportunity exists for a skilled and motivated professional to advance their career in the medical device industry.
The successful candidate will support an upcoming project at a client site in Galway, Ireland. They will contribute to manufacturing process validation, quality system updates, and documentation remediation.
Key Responsibilities
* Analyse specifications and performance requirements for processes, products, materials, or equipment.
* Compile and analyse operational, test, and experimental data to establish performance standards.
* Summarise and draw conclusions from test results to achieve effective technical resolution.
* Troubleshoot new products and processes while working closely with product development teams.
* Drive improvements in process design, layout, and operational performance.
* Apply good working knowledge of validation techniques and associated regulatory requirements.
* Promote and participate in cross-functional teamwork environments.
* Evaluate new equipment, processes, or chemicals for environmental impact and implement measures to eliminate or lessen such effects.
* Ensure compliance with regulations governing quality systems.
Requirements
* Engineering or Quality degree with 2-3 years' relevant industry experience.
* Background in remediation, process validation, CAPA, NCRs.
* Strong technical writing and documentation skills.
* Knowledge of 21 CFR Part 820 and ISO 13485.
What We Offer
* Competitive employee compensation package.
* Pension contributions.
* Health insurance.
* Paid public holidays.