Design Quality Assurance Engineer
We are seeking a proactive and quality-focused Design Quality Assurance Engineer to play a pivotal role in ensuring that our design processes meet regulatory requirements and deliver exceptional results.
Your Key Responsibilities:
* Support design control processes and ensure compliance with industry regulations.
* Act as the quality representative in projects, providing expert guidance from start to finish.
* Manage change control processes by collaborating across departments like R&D, Operations, and Labelling.
* Lead risk management activities, including creating and maintaining Risk Management Files.
* Facilitate failure mode and effects analysis (FMEA) meetings and other critical quality initiatives.
* Provide training to team members on design and change control requirements.
* Perform post-market surveillance and internal audits to maintain top-tier compliance.
About You:
* You will have a BSc in Science, Engineering, or Quality Assurance, plus at least 2 years of experience in a quality function.
* You will have knowledge of risk management practices, with experience in the IVD or medical device industry being a bonus.
* You will be familiar with standards like FDA 21 CFR820, ISO13485, and IVDR EU/2017/746.
* You will possess exceptional communication and interpersonal skills to collaborate across teams.
* You will have strong problem-solving skills and meticulous attention to detail.
About 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, and a chance to grow professionally while making a tangible difference in people's lives.