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Principal Quality Engineer
@Proscia
[Hiring] Principal Quality Engineer @Proscia
Mar 26, 2025 - Proscia is hiring a remote Principal Quality Engineer. đź’¸ Salary: unspecified. đź“ŤLocation: USA.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
As a Principal Quality Engineer, you’ll play a critical role in driving the quality and compliance of our cutting-edge software products that power the future of digital pathology. You’ll work at the intersection of engineering, product, and regulatory excellence—guiding our teams to deliver high-performing, compliant, AI-driven medical device software.
- 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 Proscia’s 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 Proscia’s 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 appropriate—modeling the AI-first mindset Proscia expects of all team members.
Qualifications
- 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-making—AI fluency is a must.
Benefits
- 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.
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| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
QA
QA
|
Salary
đź’¸
unspecified
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 26, 2025
|
️
| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
