Senior Principal Specialist, Quality Assurance (Design)
Leica Biosystems
Miami, FL
9 days ago
Job Description
Join Leica Biosystems as a Senior Principal Specialist in Quality Assurance, where you'll lead Design Control activities for groundbreaking medical devices. Collaborate across functions and globally to ensure top-tier product quality, while mentoring the next generation of Quality Assurance professionals. Make a significant impact in the field of cancer diagnostics.
Key Responsibilities
Serve as Quality Assurance lead for Design Control on critical new product development projects
Collaborate globally and cross-functionally to achieve project goals and meet timelines
Critically review and approve analytical and clinical study protocols and reports
Define regulatory strategy and plans for clearance/approval of technologies
Mentor and coach Quality Assurance professionals
Required Qualifications
Extensive experience in medical device industry covering Innovation and Design Control
Proven experience supporting submissions for high-complexity diagnostic products globally, specifically 510(k) and PMA submissions in the USA
Extensive knowledge of international IVD medical device quality systems including 21 CFR 820, ISO 13485, MDSAP
Substantial experience in commercial product development and transfer of complex feasibility projects into product commercialization
Experience in support of New Product Development for high complexity products
Preferred Qualifications
Previous experience in IVD, Companion Diagnostics, and/or digital fields
Collaborating with external stakeholders like suppliers and academia
Knowledge of FDA and EU requirements for Design Control activities for IVDs and/or medical devices