Job Title: Quality Assurance Specialist
This is an exciting opportunity to join a manufacturing site that has undergone major investment and expansion. You will be working with a very friendly and experienced team that have a wealth of experience in the leadership team.
About The Role:
We are seeking a skilled Quality Assurance Specialist to join our team. As a key member of our operations, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.
Your primary focus will be on developing and implementing solutions to sustain and improve our QMS. This includes maintaining and supporting compliance to ISO and ISO systems standards, participating in the site change control process, and generating risk assessments.
You will also be responsible for reviewing and executing Factory Acceptance Testing and Site Acceptance Testing protocols, directly supporting GMP and regulatory audits, preparing and delivering training modules, and performing data analysis.
Responsibilities:
1. Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
2. Developing and implementing solutions to sustain and improve the QMS.
3. Maintain and support compliance to ISO and ISO systems standards.
4. Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
5. Generation of risk assessments, covering cleaning, validation, and process.
6. Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
7. Directly supports GMP and regulatory audits.
8. Prepare and deliver training modules as required.
9. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
10. Support continuous improvement through Lean Six Sigma methodologies.
11. Execution/development of change controls.
12. 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.;
13. Implement subsequent corrective action through the change management system.
14. 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 essential.