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.
- Educated to a minimum of degree level in Science/Engineering/QA or related discipline.
- A minimum of 2 years practical experience required in a quality function.
- 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.
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
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.