We are proudly partnering exclusively with Arrotek Medical, a leading engineering and manufacturing organisation serving the European and US medical device market. Based in Sligo, Arrotek offers an exciting opportunity for a Quality Inspector on an initial 6 month contract.
Responsibilities:
1. Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.
2. Routine Final QA Product Inspections of finished parts in production by confirming specifications; conducting visual and measurement tests; communicating any non-conformances to Production Manager & Quality Dept.
3. Routine Environmental Monitoring; pressure differential readings, Particulate Monitoring, Microbial Monitoring.
4. Document inspection results by completing reports and logs; inputting data into quality database.
5. Problem solving and continuous improvement investigations.
6. Perform internal audits as required.
7. To provide assistance and support to the Quality Engineering and Operations function.
8. Drive continuous improvement and best practices in QMS "Right First Time".
9. Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.
10. Updates job knowledge by participating in educational opportunities.
11. Ensure compliance to all applicable regulatory standards and cGMP procedures and practices.
12. Documentation Control:
13. Review documentation for completeness.
14. Responsible for scanning, filing, backing up and archiving quality documentation to maintain Arrotek's quality management system.
15. Maintain and control all external supplied documentation which may affect product realisation.
Requirements:
16. Leaving Cert plus minimum 1 year experience as a Quality Inspector in Medical Devices.
17. Proficient computer skills.
18. Understand general principles of EN ISO 13485 & FDA 21 CFR 820.
19. Competent in Inspection method and reading drawings and specifications.
20. Decision-making ability coupled with the ability to work on one's own initiative and with minimum supervision is required, and ability to multitask and prioritise.
21. Good interpersonal skills and organisational skills.
22. Excellent attention to detail.
23. Competent in inspection methods and reading drawing and specifications.
24. Understand the principles of product/parts and FIFO.
25. Communicates any concerns about work process regarding environment impact, health or safety issues to their manager.
26. Forklift Licence would be an advantage.