You are visiting this website from:
View All Jobs

Senior Quality Engineer

Job Seekers Ireland Engineering, Science Life Science, Manufacturing, Pharmaceutical

Job Summary

  • Dublin
  • Permanent
  • BBBH798154
  • Dec 20, 2021
  • Competitive
Job Description

This is an exciting new role for a Senior Quality Engineer which will support design and development projects within the team.

This person will have practical experience working with design teams and providing design assurance support in line with regulatory requirements. You will have extensive knowledge and experience working towards ISO 13485 and ISO 14971, and experience in medical device regulations (EU MDR 2017/745) is also advantageous. This person will ideally come from an R&D background with experience in quality operations. You must have a degree in science, engineering, or quality with minimum 5 years' experience in a high-volume manufacturing medical device or pharmaceutical industry. The successful person will be motivated and driven to come in and hit the ground running. Teamwork and communication are essential for this role.

Responsibilities include:

  • Overseeing program activities, risk management, validation and QMS activities across the team working in line with the Design and QA Manager.
  • Ensure design and development projects are executed in line with regulatory, international, and local standards.
  • Responsible for reporting on the progress of projects regarding success, compliance, and quality related issues - escalating as appropriate.
  • Generations of risk management plans and summary reports on design and development projects.
  • Review and approve validation documents and support the completion of pre-QC checklist.
  • Responsible for driving the closure of change controls and protocol deviations.
  • Support the supplier selection process.
  • Conduct internal audits, supplier audits and support and preparation for hosting 3rd party and customer audits.

If this role is of interest, please 'apply now'.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

broadbean-tracking

Consultant Details

Consultant Details

Aoife O'Driscoll
Aoife O'Driscoll
  • Consultant
  • +353 (0) 21 2300300
  • aodriscoll@morganmckinley.com