Principal Quality Engineer

ZipRecruiter; Philadelphia (Philadelphia County); Remote; USD 100,000 - 130,000; Full time

Job summary

A leading company in medical technology seeks a Principal Quality Engineer to enhance the quality of AI-driven software in digital pathology. This role requires significant experience in the medical device field and expertise in software compliance, where you'll contribute to innovative projects aimed at transitioning pathology into the digital age.

Qualifications

• 10+ years in medical device design, 4+ years in software quality.
• Advanced knowledge of ISO 13485, ISO 14971, and IEC 62304.
• Proven leadership in quality initiatives and process improvements.

Responsibilities

• Drive quality and compliance of medical device software products.
• Ensure adherence to design controls and software development life cycle.
• Collaborate on risk management and continuous improvement initiatives.

Skills

Agile software development

Risk management

Communication

Root cause analysis

AI fluency

Education

Bachelor's degree in engineering, science, or related field

Job description

Job DescriptionJob DescriptionSalary:

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 pathologys transition from microscope to imagesand to use AI to change the way we think about cancer.

We cant change medicine alone. Thats why were 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
As a Principal Quality Engineer, youll play a critical role in driving the quality and compliance of our cutting-edge software products that power the future of digital pathology. Youll work at the intersection of engineering, product, and regulatory excellenceguiding our teams to deliver high-performing, compliant, AI-driven medical device software.

What Youll Do
Working at a startup like Proscia means wearing many hats, but when you come to work you can expect to focus on the following:

• Ensures new product development activities and records are in accordance with regulations (such as ISO 13485, ISO 9001, ISO 14971, IEC 62304, IEC 82304, and 21 CFR 820) and company policies.
• Coach, mentor, teach, and influence colleagues in best quality practices and compliance with Proscias quality management system.
• Provides guidance for software product development under design controls and AGILE Software Development Life Cycle processes: User and Product requirements, Design Specifications, Configuration Management, Design Verification/Validation, Design Reviews, Pre- and Post-Market Product Changes.
• Provide quality assurance support and oversight for Proscias products throughout the software development lifecycle, including Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes, Defect Management, and Post-Market Surveillance.
• Understand user needs and assure they are translated to the design, while ensuring compliance with usability and human factors standards and regulations.
• Partner with engineering and product colleagues to define design inputs and outputs, plan verification and validation activities and design reviews, and produce traceability matrices.
• Actively participate with design teams on developing product Risk Management Files; ensure risks are assessed and adequately addressed in compliance with company policies and ISO 14971 as applicable.
• Support cybersecurity activities including security risk management, pre-market submission documentation, and post-market management.
• Assist in supplier selection, qualification, periodic audits, and performance improvement.
• Support intended use validation for non-product software and tools used in the development process (computer systems validation).
• Support internal QMS audits and external regulatory and customer audits as the product quality subject matter expert.
• Support nonconformance and CAPA investigations and improvement action plans.
• Collaborate with cross-functional development teams to drive efficiency and continuous improvement.
• Leverage AI-enabled tools (e.g., ChatGPT, GitHub Copilot) to enhance productivity and simplify documentation where appropriatemodeling the AI-first mindset Proscia expects of all team members.
  

What Were Seeking
Were looking for people who are smart, nice, & get stuff done. Proscia is a high-growth company, and we want entrepreneurial doers that thrive in a challenging environmentready to build the plane while flying it. Proscias next Principal Quality Engineer will have:

• 10+ years of experience in a medical device design environment, with at least 4+ years focused on software quality.
• Strong working knowledge of Agile software development processes and best practices for design control.
• Bachelor's degree or similar coursework in engineering, science, mathematics, or related technical field.
• Advanced knowledge of ISO 13485, ISO 14971, and IEC 62304, with practical application experience.
• Demonstrated ability to lead cross-functional quality initiatives, manage risk, and drive results in a lean, fast-paced environment.
• Familiarity with cybersecurity risk management, human factors engineering, and clinical validation practices.
• Proven skills in root cause analysis, CAPA, and quality systems management.
• Clear and compelling communication skills with the ability to influence across levels and functions.
• Experience using or exploring AI tools to improve workflow, documentation, and decision-makingAI fluency is a must.
  

Beyond Just Work

Our office environment is designed for creativity and agility: with walls as notepads and couches for collaboration. Were 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 dont just accept differenceswe 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

remote work