36 applicants
This job has closed.
Subtle Medical · 2 days ago
Platform Design Control Quality Engineer
United States
Full-time
Hybrid
Entry Level
0+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesArtificial Intelligence (AI)Health Care
Insider Connection @Subtle Medical
Responsibilities
Lead project management for the Platform, including using Atlassian Jira software development practices
Support the Platform Product manager
Drive Design Control for Platform components including planning, design inputs, design outputs, labeling, software verification and validation, risk management, design review, traceability analysis, design transfer, deployment, defect management
Participate in resolution of Platform-related defects, complaints, and feedback
Develop IT/Cybersecurity/Privacy, Quality, and Regulatory related story tickets for the Platform to improve compliance and automated records
Partner with software engineers to draft and execute manual test cases in TestRail
Lead third-party and internal tool qualification
Tool specification and risk assessment
Manual test case writing and execution of tool qualification
Monitoring and documented review of new versions of tools, including requalification testing if needed
Partner with Supplier Quality Lead to complete supplier files for the suppliers of third-party tools
Drive Design Control-like process for Data Management System (DMS) tool being internally developed
Participate in annual security assessment activities, e.g. annual SOC 2 Type II audits
Collecting evidence (screenshots, policies, etc)
Coordinating responses as needed from other stakeholders
Participate in vulnerability management program
Assist with reviewing and opening tickets to resolve vulnerabilities discovered during annual penetration tests, monthly vulnerability scans, or scans of third party dependencies
Assist with updates to IT and Security documentation
Support internal/external QMS audits, NC/CAPA, Defect Management, and Risk Management as assigned
Support and participate in other duties as assigned, with priority for the interests and skill sets of the candidate
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor’s degree in a relevant field, Master’s degrees are welcomed
0-2 years of relevant work experience
Cross-functional collaboration, communication, and project management skills
Technical writing skills, document formatting skills, and knowledge of Good Documentation Practices (GDP)
Basic knowledge of Quality Management System and medical device regulations
Proficient Google Drive or Microsoft Office tools
Proficient with remote working tools (chats, video conference, etc.)
Ability and willingness to learn new skills and specializations
Executing projects with multiple stakeholders
Summarizing regulation / laws into reports (or equivalent such as a literature review)
Following up with stakeholders for a project
Technical writing, document formatting, diagram making
Preferred
Software Engineering experience and automated test development experience
Working knowledge of Quality Management System (QMS) regulations and applicable familiarity with ISO 13485, ISO 14971, IEC 62304, and IEC 62366, ISO 27001, GDPR, CCPA/CPRA
Nonconformance (NC)/Corrective and Preventive Action (CAPA) with Root Cause Analysis (RCA) experience
Information design skills to make pretty diagrams, tables, and charts
Familiar with tools: TestRail, Atlassian Jira, Atlassian Confluence, and eQMS
Familiar with medical devices, radiology, artificial intelligence
Prior internship or full-time work in related areas
Company
Subtle Medical
Subtle Medical is a healthcare technology company that offers AI-powered medical imaging.
11-50 employees
H1B Sponsorship
Subtle Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
2022 (4)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$59.2MKey Investors
Fusion FundNational Institutes of HealthBessemer Venture Partners
2024-05-13Series B· $10M
2023-09-13Grant· $2.3M
2022-11-17Series B· $25M
Leadership Team
Enhao Gong
Founder and CEO
Company data provided by crunchbase
