Quality Inspector – Documentation Control

Arrotek Medical is a medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market. We strive to provide employees the opportunity to work in a competitive, growing and dynamic environment, for career development and employee wellness through providing a competitive employee package.

For further information on Arrotek Medical, visit http://www.arrotek.com

We are currently recruiting for the Quality Inspector – Documentation Control (panel).


The responsibilities for this position will include the following:

Quality Inspector

  • 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.
  • Review and update QA Documentation.
  • 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.
  • 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.

Documentation Control

  • As above +
  • 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.
  • 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.

Interested applicants should submit their up to date CV and Cover Letter to
[email protected]. All applications will be treated in strict confidence.

Arrotek Medical is an equal opportunities employer.

Our Medical Device Design Work