Leading Quality Assurance Specialist

Job Title: Quality Assurance Lead Job Summary: We are seeking a skilled Quality Assurance Lead to join our team. The successful candidate will be responsible for ensuring the quality of our medical devices and developing strategies to drive project results. Key Responsibilities:Serve as Quality Assurance lead for Design Control covering business-critical new product development projects and external partnership programs, including ensuring that state-of-the-art requirements are maintained throughout the product lifecycle.Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Regulatory Affairs, Research and Development, Product and Program Management) to achieve project goals and meet timelines.Critically review and approve analytical and clinical study protocols and reports to assess quality, identify gaps, and provide mitigations that support successful new product development, bringing high-quality product to market.Define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD, and Companion Diagnostics markets, including providing input into 510(k), PMA and companion diagnostic submissions and acting on regulatory intelligence changes to ensure minimal impact to current and future portfolio.Mentor and coach LBS Quality Assurance professionals in their development and support building team capabilities.

Created: 2025-07-24