
Process Improvement Specialist
7 days ago
Job Description:
We seek a seasoned Manufacturing Engineer to join our team in Galway, Ireland. This role involves supporting an upcoming project by validating manufacturing processes, updating quality systems, and remediating documentation.
Key Responsibilities:
- Analyze specifications and performance requirements for processes, products, materials, or equipment.
- Under broad supervision, compile and analyze operational, test, and experimental data to establish performance standards for new products or processes.
- Summarize, analyze, and draw conclusions from test results leading to effective technical resolutions.
- Troubleshoot new products or processes while working closely with product development teams.
- Continuously drive improvements in process design, layout, and operational performance.
- Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements.
- Actively promote and participate in cross-functional teamwork environments.
- Evaluate new equipment, processes, or chemicals for environmental impact or effects.
- Comply with all regulations governing quality systems.
Requirements:
- Engineering or Quality degree with 2-3 years' relevant industry experience.
- Background in remediation, process validation, CAPA, and NCRs.
- Strong technical writing and documentation skills.
- Knowledge of 21 CFR Part 820 and ISO 13485.
Benefits:
- Competitive employee compensation package.
- Pension contributions.
- Health insurance.
- Paid public holidays.
Location: Galway, Ireland | Onsite.
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