Job Description:
As a Design Quality Assurance Engineer, you will play a pivotal role in ensuring that our design processes meet regulatory requirements and deliver exceptional results.
You will work alongside cross-functional teams, combining your quality expertise with strategic thinking to drive projects from concept to product launch.
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:
We are looking for someone with a proactive mindset and a passion for quality.
Ideal qualifications include:
* 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 21 CFR820, ISO13485, and IVDR EU/2017/746.
* Exceptional communication and interpersonal skills to collaborate across teams.
* Strong problem-solving skills and meticulous attention to detail.
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