[ref. a38630504] Longford - Quality Validation Engineer - Medical Device New

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]

• 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
• Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.

• 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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