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:
- Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.
- 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.
- Routine Environmental Monitoring; pressure differential readings, Particulate Monitoring, Microbial Monitoring.
- Document inspection results by completing reports and logs; inputting data into quality database.
- Problem solving and continuous improvement investigations.
- Perform internal audits as required.
- To provide assistance and support to the Quality Engineering and Operations function.
- Drive continuous improvement and best practices in QMS “Right First Time”.
- Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.
- Updates job knowledge by participating in educational opportunities.
- Ensure compliance to all applicable regulatory standards and cGMP procedures and practices.
- Documentation Control:
- Review documentation for completeness.
- Responsible for scanning, filing, backing up and archiving quality documentation to maintain Arrotek’s quality management system.
- Maintain and control all external supplied documentation which may affect product realisation.
Requirements:
- Leaving Cert plus minimum 1 year experience as a Quality Inspector in Medical Devices.
- Proficient computer skills.
- Understand general principles of EN ISO 13485 & FDA 21 CFR 820.
- Competent in Inspection method and reading drawings and specifications.
- 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.
- Good interpersonal skills and organisational skills.
- Excellent attention to detail.
- Competent in inspection methods and reading drawing and specifications.
- Understand the principles of product/parts and FIFO.
- Communicates any concerns about work process regarding environment impact, health or safety issues to their manager.
- Forklift Licence would be an advantage.
For more information and a confidential discussion on the role of Quality Inspector Sligo, please contact Emma Cawley.