Job Description
About the Role
We are seeking an experienced Validation Quality Engineer to support the successful qualification of new tools and product introductions on-site.
Key Responsibilities
* Develop and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
* Implement solutions to sustain and improve the Quality Management System (QMS).
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Generate risk assessments covering cleaning, validation, and process.
* Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
* Directly support Good Manufacturing Practice (GMP) and regulatory audits.
* Prepare and deliver training modules as required.
* Analyze data and make informed decisions/recommendations around conclusions reached from data analysis.
* Sustain continuous improvement through Lean Six Sigma methodologies.
* Execute/develop change controls.
* Analyze system failures/substandard performance using standard tools/methods to resolve machine/system issues.
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.
* Minitab.
* 8D.
* KPI trending and analysis.
Becoming a part of our team requires strong skills and qualifications. As a professional, you will be working closely with various departments, collaborating and contributing to business success.