Web Application Tester
The Krazy Coupon Lady
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Director, Design Quality Assurance (Hybrid)
Diabetes Youth Families
full-time
Posted on:
Location: California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $168,075 - $252,113 per year
Job Level
Lead
Tech Stack
CloudCyber Security
About the role
- Direct the Design Assurance organization to support new product development and sustain activities for digital and cloud-based medical products.
- Develop and implement comprehensive design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements.
- Ensure compliance with global regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 82304) for Class II and III devices.
- Oversee design controls, risk management, usability, cybersecurity, and AI/ML validation throughout the product lifecycle.
- Guide cloud development activities and ensure quality in the deployment of cloud-related medical devices and their interactions with enterprise IT infrastructure.
- Ensure seamless integration of digital products with broader system components including hardware, firmware, and enterprise platforms.
- Apply risk-based decision-making and lead risk assessments to support innovation, safety, and compliance.
- Lead internal and external audit readiness, including FDA inspections and notified body assessments.
- Hire, develop, and retain top DQA talent while fostering a high-performance, agile, and collaborative team culture.
- Continuously improve quality systems, tools, and processes to support digital product excellence in a fast-paced environment.
- Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.
- Serve as a subject matter expert on SW design quality matters, providing expertise and support to cross-functional teams and external partners.
- Develop and deliver Design Control training for the software development organization.
- Establish and maintain design quality, SW metrics and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives.
Requirements
- Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.
- 10+ years in software design quality assurance within the medical device or medical digital health industry.
- 7+ years in a leadership role overseeing design quality and/or DQA for digital products.
- Significant breadth and depth in quality decision-making, risk management, and quality engineering.
- Experience with software mobile applications, cloud-based systems, and cybersecurity.
- Experience in the development and implementation of effective Design Control Systems.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
- Working knowledge of IEC 62304/82304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k).
- Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
- Experience with software development lifecycles with emphasis on the software quality engineering aspects.
