* Engineering (Design/ R&D / Mechanical / NPI)
Our Client, a leading Medical Device company based in Sligo, is seeking a Quality Inspector to join their team. The successful candidate will play a critical role in the quality and documentation of incoming goods and will work with a high level of attention to detail and technical expertise that will contribute to maintaining high standards within the department.
Responsibilities include but are not limited to:
1. Approve incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.
2. Conduct routine Final QA Product Inspections of finished parts in production by confirming specifications, conducting visual and measurement tests, and communicating any non-conformances to the Production Manager & Quality Dept.
3. Document inspection results by completing reports and logs; inputting data into the quality database.
4. Engage in problem-solving and continuous improvement investigations.
5. Perform internal audits as required.
6. Review and update QA Documentation.
7. Provide assistance and support to the Quality Engineering and Operations function.
8. Drive continuous improvement and best practices in QMS “Right First Time”.
9. Maintain a safe and healthy work environment by following standards and procedures; complying with legal regulations.
10. Update job knowledge by participating in educational opportunities.
11. Ensure compliance with all applicable regulatory standards and cGMP procedures and practices.
12. Review documentation for completeness.
13. Responsible for scanning, filing, backing up, and archiving quality documentation to maintain the company’s quality management system.
14. Maintain and control all externally supplied documentation that may affect product realization.
15. Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Job requirements
1. Leaving Cert plus a minimum of 3 years of Medical Device assembly experience.
2. Understanding of general principles of EN ISO 13485, FDA 21, CFR 820.
3. Competent in inspection methods and reading drawings and specifications.
4. Decision-making ability coupled with the ability to work on one’s own initiative and with minimum supervision; ability to multitask and prioritize.
5. Good interpersonal and organizational skills.
6. Excellent attention to detail.
7. Understanding of the principles of product/parts and FIFO.
8. Communicate any concerns about work processes regarding environmental impact, health, or safety issues to their manager.
9. A forklift license would be an advantage.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.
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