Principal QA Scientist

Principal Design Control Scientist – NE/ Tyne & Wear– Diagnostics

About the Company:

We are looking for a quality professional with extensive experience in compliance for product development and design control, to work for a leading diagnostics company. This is a fully site-based role within a newly formed team.

Responsibilities:

• Support site projects that drive new product development (NPD) and product lifecycle management (PLCM).
• Provide Design Control leadership and collaborate across LBS and Danaher sites.
• Improve processes to reduce variability and strengthen product robustness.
• Lead functional teams or medium-scale projects as needed.
• Partner with Regulatory Affairs on global submissions, including FDA 510(k), PMA, and IVDR CE documentation.

Requirements:

• Strong knowledge of Design Controls and design/development practices for medical device or diagnostic products.
• Extensive experience in medical device development and quality systems.
• Expert understanding of standards such as 21 CFR 820, ISO 13485, ISO 14971, and MDSAP.
• Proven Quality leadership experience.
• Bachelor’s degree in a scientific, or technical discipline.