Quality Inspector - Documentation Control
We are currently recruiting for the Quality Inspector - Documentation Control for a medical device engineering company based in Sligo
The responsibilities for this position will include the following:
- Approving 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-conformance 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.
- Performing internal audits as required.
- Review and update of QA Documentation.
- Providing assistance and support to the Quality Engineering and Operations function.
- Driving continuous improvement and best practices in QMS "Right First Time".
- Maintaining safe and healthy work environment by following standards and procedures; complying with legal regulations.
- Updating job knowledge by participating in educational opportunities.
- Ensuring compliance to all applicable regulatory standards and cGMP procedures and practices.
- 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
- Reviewing documentation for completeness.
- Scanning, filing, backing up and archiving quality documentation to maintain company's quality management system.
- Maintaining and controlling all external supplied documentation which may affect product realisation.
- 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.
Other such duties as may be assigned from time to time by their Manager.
Candidates likely to be called for interview will have most or all of the following:
* Leaving Cert plus minimum 3-year Medical Device assembly experience.
* 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.
* Documentation skills.
* 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.
This is a full-time position on a Permanent contract.