Collins McNicholas

The position requires an experienced and proven candidate with a background in Quality and Regulatory control of Medical Devices. The successful candidate will work as part of a team to maintain high quality/performance standards across the company.

Reporting to the Senior Quality / Regulatory Manager, the position will be challenging and will require an ability to work autonomously

Roles & Responsibilities

The Senior Quality Engineer shall:

  • Act as the QA representative on Design Services Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation.
  • Develop and maintain documentation in compliance with FDA, ISO, MDD requirements
  • Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)
  • Initiate / Approve Engineering Change notices
  • Process Customer Complaints and manage customer replies
  • Actively participate in the Documentation control process
  • Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
  • Participate / Lead Risk Analysis initiatives e.g. FMEA
  • Initiate / Approve Reworks
  • Initiate / Support implementation of effective Corrective / Preventive Actions
  • Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.
  • Represent QA as part of the Material Review Board
  • Perform Internal and Supplier Audits
  • Support Notified Body / Regulatory Agency / Customer Audits
  • Review / Approve / Release final product documentation
  • Support the Environmental monitoring process
  • Support activities associated with Sterilization
  • Act as the QA representative for Supplier Quality management activities
  • Collate and trend Key performance indicator data
  • Actively participate in Management Review & Compliance meetings
  • Act as delegate for Quality Manager when required
  • Performs other related duties, as assigned


 Role Requirements

A degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 5 yrs. experience within the Medical Device Industry.

Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.

Experience of using Lean Manufacturing Tools and Techniques an advantage

Quality Certification and Lead Auditor Certification while not mandatory would be an advantage.


For a confidential discussion and a more detailed job description (or more information on the role), please contact Christopher O Toole on 091706713 

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