Quality Engineer I
About Your New Employer
This is an expanding start-up medical device company based in Galway focused on developing a novel device for treatment.
About Your New Job as a Quality Engineer:
This is an ideal role for someone who thrives in a dynamic environment, is naturally curious, and is motivated by the potential to improve patient outcomes through innovative technology.
As a Quality Engineer I, you’ll play a pivotal role in supporting the development and implementation of quality systems as the company advances from product development into commercialisation. You’ll collaborate closely with internal teams and manufacturing partners during a transformative phase of growth.
Support design and development initiatives, including design controls, verification, and validation activities.
Contribute to the development and validation of test methods and computer system assurance programs in line with regulatory requirements.
Collaborate with cross-functional teams to uphold quality policies and objectives.
Participate in risk management processes and usability engineering efforts.
Support document control activities via an electronic QMS platform (QT9), including system administration.
Lead or support investigations and resolutions related to CAPAs and non-conformances.
Participate in internal and external audits, ensuring timely follow-up on any action items.
Monitor and assess changes to relevant standards and guidance documents, conducting gap assessments as needed.
Support supplier quality activities, including selection, evaluation, and maintenance of the Approved Vendor List.
Perform additional tasks as needed to help meet business objectives and KPIs.
What Skills You Need:
A Level 8 NFQ in Engineering or Science.
Minimum of 2 years’ experience in medical device manufacturing.
Familiarity with FDA and EU regulatory requirements, including QSR and ISO standards.
Demonstrated ability to manage priorities, solve complex problems, and lead technical initiatives.
Knowledge of risk management principles (ISO 14971) and strong root cause analysis skills (e.g., DMAIC).
Proficiency in MS Office suite and experience working in electronic QMS platforms.
What's Next?
Click 'Apply Now' or for more information, please contact eward@sigmar.ie
