Quality Validation Engineer
- Longford
- Permanent
- Full-time
- Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge
- Developing and implementing solutions to sustain and improve the QMS
- Maintain and support compliance to ISO 13485 and ISO 14001 systems standards
- Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented
- Generation of risk assessments, covering cleaning, validation, and process
- Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols
- Directly supports GMP and regulatory audits
- Prepare and deliver training modules as required
- Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis
- Support continuous improvement through Lean Six Sigma methodologies
- Execution / development of change controls
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.;
- Implement subsequent corrective action through the change management system
- Participate / lead cross functional teams including liaising with vendors on projects
- Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience
- Experience in statistical analysis (Minitab) / SPC / validations
- Excellent interpersonal, communication, influencing, and facilitation skills
- A minimum of 2 years’ experience as a Validation Engineer within an Injection moulding or medical manufacturing environment