Are you a manufacturing engineer looking to progress your career? Are you interested in taking the next step in your professional journey with a global leader in the medical device industry? Are you ready to challenge yourself in a fast-paced and high-regulated environment? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!
Job Description
Our client in Galway require experienced Manufacturing Engineers to support an upcoming project. This role will focus on manufacturing process validation, quality system updates, and documentation remediation. You will be based onsite and work directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
Key Responsibilities
- Analyse process, product, material or equipment specifications and performance requirements
- Under broad supervision / guidance compile and analyse operational, test and experimental data to establish performance standards for newly implemented or modified products / processes
- Summarise, analyse and draw conclusions from test results leading to effective technical resolution
- Troubleshoot new products / process working closely with product development
- Continually seek to drive / improvements in process design, layout and operational performance
- Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements
- Actively promotes and participates in a cross -functional teamwork environment
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
- Understands and comply with all the regulations governing the quality systems
Key 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, ISO 13485.
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid public holidays
Location: Galway, Ireland | onsite
