Job Description
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.
Key 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
* 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.
Why Work with 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 include 25 days holidays, Life assurance & health allowance, Discounts with local and national retailers, Free 24/7 Employee Assistance Programme, Recognition schemes and monetary awards, and Great long-term career opportunities.
How to Apply
To be considered for this role, click the Apply button below to Login/Register.