Quality Validation Engineer

2 weeks ago

Longford, Ireland CPL Full time
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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