Quality Assurance

4 weeks ago

Cork, Cork, Ireland LGC Group Full time
  • Department: Quality Assurance and Regulatory Affairs
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:

  1. Supporting design control processes and ensuring compliance with industry regulations.
  2. Acting as the quality representative in projects, providing expert guidance from start to finish.
  3. Managing change control processes by collaborating across departments like R&D, Operations, and Labelling.
  4. Leading risk management activities, including creating and maintaining Risk Management Files.
  5. Facilitating failure mode and effects analysis (FMEA) meetings and other critical quality initiatives.
  6. Providing training to team members on design and change control requirements.
  7. 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:

  1. A BSc in Science, Engineering, or Quality Assurance, plus at least 2 years of experience in a quality function.
  2. Knowledge of risk management practices—experience in the IVD or medical device industry is a bonus
  3. Familiarity with standards like FDA 21CFR820, ISO13485, and IVDR EU/2017/746.
  4. Exceptional communication and interpersonal skills to collaborate across teams.
  5. 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:

  1. A collaborative, supportive environment where your ideas matter.
  2. Opportunities to work on impactful projects in the healthcare sector.
  3. A chance to grow professionally while making a tangible difference in people's lives.

25 days holidays

Life assurance & health allowance

Discounts with local and national retailers

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