Director of Product Quality

About Proscia

Pathology is at the center of medicine and is undergoing a profound transformation as the final frontier of digitization in healthcare. We started Proscia to accelerate pathology’s transition from microscope to images—and to use AI to change the way we think about cancer.

We can’t change medicine alone. That’s why we’re looking for curious thinkers, big dreamers, developers, evangelists, pathologists, and scientists— exceptional talent to help us harness the great power of AI for good and advance humankind.

At Proscia, we push the limits of medicine and technology, solving problems the world has never solved before. We build software used by thousands of scientists and pathologists working on the front lines of fighting big enemies like cancer for patients around the globe. To accelerate our vision, Proscia has raised over $100M in capital from world-class healthcare and technology investors.

About This Position

The Director of Product Quality will lead a modern, user-centered quality function that integrates rigorous regulatory compliance with innovation and AI. You will be responsible for ensuring the quality and safety of our diagnostic and research software products, optimizing product development processes, and scaling best practices across the organization.

What You’ll Do

• Lead all product quality activities across the software development lifecycle in compliance with FDA QSR, ISO 13485, IVDR, and other applicable regulations.
• Drive usability and human factors engineering efforts, including formative and summative testing.
• Own and manage product risk files aligned with ISO 14971 and benefit-risk frameworks.
• Define and maintain quality metrics across products and lifecycle stages.
• Champion post-market surveillance programs leveraging customer feedback and performance data.
• Optimize design control workflows and reduce complexity through automation and AI.
• Promote AI-based tooling and practices across documentation, testing, and quality traceability.
• Partner with Engineering, Product, Clinical, and Support teams to embed quality culture across Proscia.
• Report quality trends, risks, and opportunities to executive leadership.

What We’re Seeking

• Bachelor’s or master’s degree in engineering (biomedical, mechanical, systems, or related field required).
• 10+ years in medical device development; 5+ years in leadership roles, ideally for software-based devices or digital health.
• Expertise in medical device human factors engineering and usability testing (ISO 62366).
• Deep understanding of ISO 14971, risk management practices, and benefit-risk documentation.
• Demonstrated success obtaining regulatory clearances (e.g., FDA 510(k), De Novo, CE Mark).
• Experience with software development life cycle (SDLC), design control, and SaMD.
• Track record of building and mentoring technical teams and scaling quality systems.
• Knowledge of and interest in AI tools and platforms (e.g., ChatGPT, automated test systems, traceability tools).

Beyond Just Work

Our office environment is designed for creativity and agility: with walls as notepads and couches for collaboration. We’re located in the heart of Philadelphia, with views of the city so you can spend your time focusing on what matters most.

At Proscia, we don’t just accept differences—we celebrate them, we support them, and we thrive on them for the benefit of our employees, our products, and our community. Proscia is proud to be an equal opportunity workplace