Principal Quality Assurance Engineer
RenesasElectronics
Design Quality Assurance Engineer
lgcgroup· Quality Assurance and Regulatory Affairs
About this role
Company Description
Join Us as a Design & Quality Assurance Engineer in Tipperary!
Are you ready to make a meaningful impact on healthcare?
At LGC Clinical Diagnostics, we’re passionate about improving patient outcomes with products that support accurate and reliable diagnostic results. Now, we’re on the lookout for a Design Quality Engineer to join our dynamic team in Tipperary, Ireland.
This is more than just a job; it’s an opportunity to collaborate with brilliant minds, embrace curiosity, and contribute to innovative solutions—all while living our core values of Passion, Brilliance, Curiosity, and Integrity.
At LGC Clinical Diagnostics (CDx), we're dedicated to advancing science with our comprehensive portfolio of diagnostic quality solutions and component materials. As a member of our team, you'll play a vital role in developing and manufacturing innovative diagnostic products that contribute to accurate and reliable patient outcomes.
We take great pride in upholding high standards in every aspect of our operations. As our Design Quality Engineer, you will be involved in executing projects from initiation to product launch, ensuring adherence to internal policies, regulatory requirements, and Design Control processes.
Job Description
To perform this job successfully, an individual must be able to capably perform each of the following essential functions:
Duties:
- Responsible for supporting the Design Control process and ensuring that Design History Files comply with Technopath Clinical Diagnostic (TCD) policies/procedures and applicable regulatory requirements.
- Act as the Quality representative on Design Control projects from project initiation through to product launch to ensure compliance to applicable procedures and standards.
- Manage and lead the change control process by liaising with impacted areas to ensure timely and compliant implementation and completion.
- Work in collaboration with R&D, Labelling, Operations, Validation, Business Development and Supply chain on design control and change control projects.
- Review and approve all process validation documentation inclusive of plans, protocols and reports ensuring compliance to applicable procedures and standards.
- Responsible for creation and maintenance of Risk Management Files for each product.
- Facilitate process and design failure mode and effects analysis meetings.
- Responsible for maintaining Design Control and R&D procedures to ensure compliance to regulatory or standard requirements.
- Perform Post Market Surveillance activities per the requirements of the applicable procedures and regulations.
- Liaise with external customers on change requests.
- Provide training and guidance to staff on the requirements of the design control and change control process in TCD.
- As required perform internal audits to ensure compliance of TCDs quality management system to the requirements of all applicable requirements.
- Perform other related duties as prescribed by the Global Design QA and Risk Manager and Director of Quality Assurance.
Qualifications
- Educated to a minimum of degree level in Science/Engineering/QA or related discipline or equivalent.
- A minimum of 2 years practical experience required in a quality function or equivalent
- Knowledge desirable in relation to risk management; ideally in the IVD or Medical Device industry.
- Thorough knowledge of the applicable regulatory requirements.
- Knowledge of international regulatory requirements relevant to the business.
Additional Information
Why Join Us?
At LGC Clinical Diagnostics, you’re not just another employee—you’re a valued team member contributing to a better future. We offer:
- A collaborative, supportive environment where your ideas matter.
- Opportunities to work on impactful projects in the healthcare sector.
- A chance to grow professionally while making a tangible difference in people’s lives.
Benefits
- 25 days holidays
- Life assurance & health allowance
- Discounts with local and national retailers
- Free 24/7 Employee Assistance Programme
- Recognition schemes and monetary awards
- Great long-term career opportunities
#LGCIJ
Frequently Asked Questions
Is the salary disclosed for the Design Quality Assurance Engineer position at lgcgroup?
The salary for this Design Quality Assurance Engineer role at lgcgroup is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Design Quality Assurance Engineer position at lgcgroup located?
This Design Quality Assurance Engineer role at lgcgroup is based in ie, IRELAND, Tipperary, Tipperary, IRELAND, Ireland. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Design Quality Assurance Engineer role at lgcgroup full-time or part-time?
This is listed as a Full time position. It is posted as a Design Quality Assurance Engineer role in the Quality Assurance and Regulatory Affairs department at lgcgroup.
Which team or department does the Design Quality Assurance Engineer at lgcgroup belong to?
This Design Quality Assurance Engineer position is part of the Quality Assurance and Regulatory Affairs department at lgcgroup. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Design Quality Assurance Engineer position at lgcgroup?
Click the "Apply Now" button on this page. You will be redirected to lgcgroup's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Design Quality Assurance Engineer job at lgcgroup posted?
This Design Quality Assurance Engineer position at lgcgroup was posted on Aug 5, 2026. Apply as soon as possible — early applications are often reviewed first.
Design Quality Assurance Engineer
lgcgroup
You'll be redirected to lgcgroup's official application page on SmartRecruiters.