Quality Inspector - Documentation Control

We are currently recruiting for the Quality Inspector - Documentation Control for a medical device engineering company based in Sligo

Responsibilities:
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.

Person Specification:
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.

Position Details
This is a full-time position on a Permanent contract.