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. We’re seeking 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 are dedicated to advancing science through our comprehensive portfolio of diagnostic quality solutions and component materials. As a team member, you'll play a vital role in developing and manufacturing innovative diagnostic products that contribute to accurate and reliable patient outcomes.
We pride ourselves on maintaining high standards across all operations. As our Design Quality Engineer, you will be involved in executing projects from initiation to product launch, ensuring compliance with internal policies, regulatory requirements, and Design Control processes.
Job Description
To perform this job successfully, an individual must be able to perform each of the following essential functions:
1. Support the Design Control process and ensure that Design History Files comply with TCD policies/procedures and applicable regulatory requirements.
2. Act as the Quality representative on Design Control projects from initiation to product launch to ensure compliance with applicable procedures and standards.
3. Manage and lead the change control process by liaising with impacted areas to ensure timely and compliant implementation and completion.
4. Collaborate with R&D, Labelling, Operations, Validation, Business Development, and Supply Chain on design control and change control projects.
5. Review and approve all process validation documentation, including plans, protocols, and reports, ensuring compliance with applicable procedures and standards.
6. Create and maintain Risk Management Files for each product.
7. Facilitate process and design failure mode and effects analysis meetings.
8. Maintain Design Control and R&D procedures to ensure compliance with regulatory or standard requirements.
9. Perform Post Market Surveillance activities as per applicable procedures and regulations.
10. Liaise with external customers on change requests.
11. Provide training and guidance to staff on design control and change control processes in TCD.
12. Perform internal audits to ensure compliance of TCD’s quality management system with all applicable requirements.
13. Perform other duties as prescribed by the Global Design QA and Risk Manager and Director of Quality Assurance.
Qualifications
1. Educated to a minimum of degree level in Science, Engineering, QA, or a related discipline.
2. At least 2 years of practical experience in a quality function.
3. Knowledge of risk management, ideally in the IVD or Medical Device industry.
4. Thorough knowledge of applicable regulatory requirements.
5. Understanding 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 healthcare.
* 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
#J-18808-Ljbffr