Job Opportunity
Quality Assurance Engineer
We are seeking a highly skilled Quality Assurance Engineer to join our team.
The successful candidate will be responsible for ensuring that all quality and validation activities associated with new tools/product introduction are successfully completed. They will work closely with the organisation to achieve its objectives.
Key Responsibilities:
* Develop and execute process validation protocols and reports for new product introductions and re-validations due to process/material improvements utilising scientific/technical knowledge.
* Develop and 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 execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
* Directly supports Good Manufacturing Practice (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 whys etc.
* Implement subsequent corrective action through the change management system.
* Participate/lead cross-functional teams including liaising with vendors on projects.
Required Skills and Qualifications:
* Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
* Experience in statistical analysis (Minitab)/SPC/validation.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* A minimum of 2 years' experience as a Quality Assurance Engineer within an injection moulding or medical manufacturing environment.
About the Role:
This is a fantastic opportunity to join a dynamic team and contribute to the success of our organisation. If you have a strong passion for quality assurance and a desire to work in a fast-paced environment, then this role could be perfect for you.