Manual Quality Assurance Engineer testing web and mobile applications for Planner 5D. Ensuring high quality across various platforms through manual testing and collaboration with development teams.
DF
Hybrid Director, Design Quality Assurance – NPI
Posted last week
About the role
- Director of Design Quality Assurance overseeing NPI programs for high-quality medical device introduction. Collaborating cross-functionally to ensure compliance and effective execution in a dynamic environment.
Responsibilities
- Provide strategic leadership for NPI Design Quality Assurance across all new product development programs, ensuring high-quality and compliant product introductions.
- Direct Quality Core Team Members who serve as one quality POC for the NPI Core teams for E2E product delivery.
- Work very closely with DQA leadership team for forming an extended quality core teams for each of the NPI program for successful end-to-end engagement.
- Develop and deploy DQA strategies, frameworks, and processes aligned with company goals, regulatory expectations, and industry best practices for medical device development.
- Ensure compliance with global regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 82304) for Class I, II, and III medical devices.
- Oversee all system components within NPI programs to ensure seamless integration, robust system performance, and compliance with safety and regulatory expectations.
- Oversee design controls, risk management, usability engineering, cybersecurity, AI/ML validation, and ensure timely and compliant completion of Design History Files (DHF).
- Drive end-to-end quality throughout the product lifecycle, including Product planning, system architecture reviews, requirements development, system interactions, data flows, and interoperability across system components.
- Partner with Systems Engineering to ensure system decomposition, interface specifications, and integration activities meet quality and regulatory expectations.
- Apply advanced technical expertise in software engineering, architecture assessment, verification strategy, tool validation, and cybersecurity risk evaluation to guide cross-functional teams.
- Lead cross-functional integration quality efforts across hardware, firmware, digital applications, cloud environments, and enterprise systems.
- Oversee risk-based decision-making, defect management, and software and system risk assessments to ensure product safety and regulatory compliance.
- Ensure enterprise readiness for internal and external audits, FDA inspections, and notified body assessments.
- Build, mentor, and develop a high-performing DQA organization comprising of QCTMs.
- Drive continuous improvement of quality systems, design control processes, tools, templates, and digital quality capabilities to support operational excellence.
- Serve as a senior subject matter expert in design quality assurance, guiding leadership teams, development organizations, and external partners.
- Oversee the development and delivery of training related to Design Controls, software quality, systems quality, digital compliance, and NPI best practices.
- Establish and lead metrics/KPIs for DQA performance, providing executive-level insights and driving continuous improvement initiatives across the product lifecycle.
- Other duties as assigned.
Requirements
- Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related technical discipline
- 12+ years of experience in design quality assurance, NPI quality, or related engineering functions within the medical device industry
- + years of leadership experience managing cross-functional quality teams in a regulated environment
- Proven experience leading NPI programs with complex system architectures, digital applications, cloud/software components, and connected medical devices.
- Strong expertise with FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304/82304, IEC 60601, and relevant FDA/EMA regulatory guidance.
- Demonstrated experience with design controls, DHF management, risk management, verification/validation strategy, and readiness for regulatory submissions (510(k), PMA, technical files).
- Deep working knowledge of software engineering principles, mobile development frameworks, cloud services (AWS/Azure), APIs, and digital connectivity.
- Strong understanding of Agile development, SDLC tools, and modern DevOps practices.
- Experience leading enterprise or portfolio-level quality initiatives and driving process transformation.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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