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 #LGCIJ To be considered for this role you will be redirected to and must complete the application process on our careers page.
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