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 Assurance 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 Labelling & Compliance Specialist, 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
What You’ll Be Doing
As our Design Quality Assurance Engineer, you’ll play a pivotal role in ensuring that our design processes meet regulatory requirements and deliver exceptional results. You’ll work alongside cross-functional teams, combining your quality expertise with strategic thinking to drive projects from concept to product launch.
Here’s a glimpse into your responsibilities:
- Supporting design control processes and ensuring compliance with industry regulations.
- Acting as the quality representative in projects, providing expert guidance from start to finish.
- Managing change control processes by collaborating across departments like R&D, Operations, and Labelling.
- Leading risk management activities, including creating and maintaining Risk Management Files.
- Facilitating failure mode and effects analysis (FMEA) meetings and other critical quality initiatives.
- Providing training to team members on design and change control requirements.
- Performing post-market surveillance and internal audits to maintain top-tier compliance.
Qualifications
What You Bring to the Team
We’re looking for someone with a proactive mindset and a passion for quality. Ideally, you’ll have:
- A BSc in Science, Engineering, or Quality Assurance, plus at least 2 years of experience in a quality function.
- Knowledge of risk management practices—experience in the IVD or medical device industry is a bonus!
- Familiarity with standards like FDA 21CFR820, ISO13485, and IVDR EU/2017/746.
- Exceptional communication and interpersonal skills to collaborate across teams.
- Strong problem-solving skills and meticulous attention to detail.
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
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What We Do
LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range.
LGC’s tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products.
LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community.
LGC’s core purpose of Science for a safer world and its core values of passion, curiosity, integrity, brilliance and respect, drive its culture. As of 30 June 2021, it employs 4,350 employees, of which over 1,175 employees hold PhD and/or master’s degrees. Its products and services are delivered by highly qualified and experienced teams, operating from a global network of accredited sites that showcase its scientific and manufacturing capabilities.
