Collins McNicholas


Ensure continued compliance with all Regulatory Standards. This includes:

    • ISO 13485
    • FDA QSR
    • ISO 14000
  • Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
    • Trend analysis of data from the controls
    • Potential improvements for review with engineering based on the trends.
  • Areas for Improvement to senior management.
  • Review and propose changes to sampling plans based on trend analysis and changes to the system.
  • Ensure that in your absence, your area of responsibility is covered.  Ensure that other departments are informed of your arrangements.
  • Support the Complaint/CAPA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
  • Execution of Quality Validations and preparation of associated documentation as required.
  • Review, update and approve Quality procedures as required through ECO process.
  • Action NCR and CAPA in an appropriate and timely manner.
  • Raise appropriate Variation Permits as required, in line with customer and regulatory requirements.
  • Support Customer and Regulatory Audits.
  • Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
    • Validations.
    • Engineering Change Order (ECO).
    • Complaint/Corrective and Preventative Action (CAPA).
    • Material Review Request (MRR).
    • Internal Audits.
    • Failure Mode Effect Analysis (FMEA).
    • Variation Permits (VP).
  • Project meeting attendance and provision of quality support as required.
  • Attend and participate in daily cell meetings.
  • Preparation of information for KPI and Management Review meetings.





  • Ability to communicate and work with people inside and outside the department.
  • Good communicator (written and oral).
  • Ability to train and lead where required.
  • Ability to co-ordinate, plan and organise in a timely manner.
  • Knowledge of engineering theories and methods.
  • Good technical report writing skills.
  • Rigorous attention to detail.




  • Engineering or science Degree preferably with Quality Engineering included.
  • Quality Department or similar experience in regulated industry.

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)


In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Why Inma Aguilera chose Galway for her career

Inma Aguilera, Manufacturing Process Development Engineer, Creganna Medical, Galway Beautiful scenery, a fifteen-minute commute and the opportunity to grow her career. Why Inma Aguilera is loving life in Galway! The West of Ireland is a great place for engineers to further their careers because there are so many large companies where you can grow and progress your […]
Read More