Our mission at Ezra is to detect cancer early for everyone in the world. We are currently focused on prostate cancer and have developed a new screening technology based on MRI and AI.
We believe in empowering people to make their own health decisions, so we are offering Ezra as a direct-to-consumer health membership. Our members sign up for Ezra, visit a partner imaging center to get a prostate MRI scan, and receive a cancer screening report within 48 hours. Our reports are generated by radiologists assisted by the Ezra AI, which increases accuracy and improves productivity for our radiologists.
As the QA Manager, you will implement a quality management system, train Ezra employees on the quality system, participate in projects as the quality representative, conduct risk analysis, assist in verification and validation testing, and report on key quality metrics to relevant stakeholders.
As the QA Manager at Ezra, you will:
- Work with project teams and customers to support the design and development of new products, and prepare supporting materials for government submissions to achieve marketing authorizations (i.e. FDA).
- Provide quality-related guidance to our product, engineering and business teams, to ensure quality standards are met across the whole organization.
- Guide on the interpretation of applicable standards, guidelines and guidance documents as they impact the design and development planning, design requirements and product specifications, design verification planning, etc.
- Assist in writing the project specific planning documents: Design and Development Plan, Risk Management Plan, Software Development Plan, Design Input Requirements, Verification & Validation Plan, Design Validation Protocols, Usability Protocols, etc..
- Lead the team through the risk management process including Hazard Identification, Device Hazard Analysis, DFMEA, and risk management report in compliance with ISO 14971.
- Guide the team on Human Factors/Usability Engineering requirements.
- Assist with design review meetings, records and maintain the Design History File.
- Review engineering change orders and project-related deviations and non-conformance reports.
- Perform yearly internal audit and management reviews.
- Support regulatory audits and FDA inspections.
- Act as administrator for software tools and processes that support our quality management system.
- Train Ezra employees on our quality management system and promote a culture of quality.
Who you are
You hold a Bachelor’s degree in engineering or scientific discipline, and have 5+ years of hands-on experience in the implementation and/or management of quality systems in a highly regulated environment. You are a great communicator with a strong eye for detail and passion for great software.
- Bachelor’s degree in software engineering
- In-depth working knowledge of US FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304.
- Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
- Strong analytical, problem solving and decision-making skills; exercise sound judgement in applying these skills.
- Strong verbal (including presentation) and written communication skills, especially technical writing (plans, protocols, reports).
- RAC or ASQ certifications is a plus.
- Experience working in an Agile environment is a plus.
- Experience with supporting regulatory audits and FDA inspections is a plus.
- Experience in running quality management systems and documentation using Confluence and Jira is a plus.
What’s in it for you?
As the QA Manager at Ezra, you have the opportunity to be an early member of our all-star team focused on early detection of cancer for everyone in the world. You’re also going to have access to benefits such as:
- Stock options
- Comprehensive health, dental and vision plans for your and your family
- Wellness and commuter benefits
- Competitive vacation policy
- A culture that emphasizes learning and work-life harmony
- Healthy food and snacks
- Off-sites and happy hours
Our commitment to diversity and inclusion
We’re aiming to build a diverse team and inclusive company culture. We do not discriminate based on race, color, ethnicity, ancestry, national origin, religion, sex, gender, gender identity, gender expression, sexual orientation, age, disability, veteran status, genetic information, marital status or any legally protected status.