Experienced Validation Quality Engineer required for medical device manufacturing facility in Longford. Will support the successful qualification of new tools / product introduction on-site. Permanent role with benefits. If interested, do email an updated word copy of your CV [email protected]
Role
· 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.
Requirements
· 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
· Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.
Quality Tools
- Root cause investigation
- DEMAC Tools
- Six Sigma – minimum Green belt
- Good knowledge of plastic processing
- SPC
- Mini Tab
- 8D
- KPI Trending and analysis
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