Quality Assurance Engineer ensuring compliance across ground segment systems at CROWDCONSULTANTS. Monitoring QA activities and supporting engineering lifecycle in highly regulated space environment.
DF
Hybrid Director, Design Quality Assurance – NPI
Posted 3 days ago
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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