Vice President, Product Design Quality

Role Description

The Vice President, Product Design Quality is a senior quality leadership role reporting directly to the SVP, Quality & Regulatory Affairs. This leader is responsible for establishing and driving a world-class Design Quality organization across hardware, software (SaMD), and risk management functions.

This role provides strategic and operational leadership for all design quality activities across the product lifecycle from early feasibility through commercialization and post-market changes ensuring compliance with global regulatory requirements and enabling scalable innovation.

The VP will play a critical role in regulatory remediation efforts, including leading responses to FDA warning letters, hosting regulatory inspections, and transforming design control and risk management processes into a sustainable, inspection-ready state.

This role is critical to ensuring the organization delivers safe, effective, and compliant products while enabling innovation and growth.

Responsibilities

• Lead and scale the Design Quality organization, including hardware, software (SaMD), and risk management teams.
• Build a high-performing organization with strong talent development, succession planning, and capability building.
• Ensure quality and regulatory considerations are embedded in product portfolio strategy, product development, and lifecycle management.
• Establish Design Quality as a strategic business partner to R&D, Clinical, Regulatory, and Operations.
• Partner closely with R&D leadership to ensure quality is embedded early and effectively in development programs.
• Partner with R&D, Clinical, Operations, Manufacturing, and Commercial, to ensure alignment and compliance.
• Influence product development strategy through risk-informed and compliance-driven decision making.
• Provide quality and regulatory leadership throughout product development, verification/validation, and commercialization.
• Ensure design controls, clinical evaluation, and risk management activities meet regulatory requirements (ISO 13485, FDA QSMR/ 21 CFR part 820, EU MDR, ISO 14971, SaMD and cybersecurity regulations).
• Own and continuously improve Design Control, Design Transfer, and Risk Management processes across hardware and software products.
• Ensure robust quality oversight from concept through commercialization, including new product introduction and global product transfers.
• Drive integration of quality into agile and AI/algorithm development environments for SaMD.
• Ensure effective application of quality engineering principles (verification/validation, clinical evaluations, risk analysis, human factor analysis, product validation, etc.).
• Drive transformation and harmonization of Design Quality processes within the Quality Management System (QMS).
• Establish metrics, dashboards, and governance mechanisms to monitor product quality and design process effectiveness.
• Lead cross-functional initiatives to improve product development efficiency, compliance, and quality outcomes.
• Ensure alignment between design & risk quality, manufacturing quality, and post-market surveillance.
• Support portfolio prioritization and innovation efforts with quality insights.
• Serve as the lead for FDA inspections and Notified Body audits, as it relates to design controls, and risk management.
• Translate evolving regulatory design control requirements into scalable internal procedures and systems.
• Oversee enterprise product risk management function, ensuring alignment with ISO 14971.
• Ensure risk-based decision-making is embedded across product development and lifecycle management.
• Strengthen linkages between risk management, clinical evaluation, and post-market data.

Qualifications

• 15+ years of progressive leadership experience in Medical Device Quality and/or Design Quality.
• Proven experience leading Design Quality organizations across the product development lifecycle.
• Demonstrated success building, developing, and leading high-performing teams.
• Expertise in design controls, design transfer, and risk management.
• Experience supporting connected medical devices and prior experience partnering with Software as a Medical Device (SaMD) teams.
• Significant FDA inspection and audit management experience.
• Experience leading FDA responses, remediation efforts, and inspection readiness activities.
• Strong understanding of FDA regulations, ISO 13485, ISO 14971, and global regulatory requirements.
• Experience conducting risk-benefit analyses and making quality decisions in highly regulated environments.

Ways to Stand Out

• Cardiovascular medical device experience.
• Experience supporting AI-enabled products or digital health technologies.
• Demonstrated ability to influence cross functional stakeholders; executive communication skills.
• Demonstrated business acumen and ability to connect quality strategy to business outcomes.

Location

Remote - US

Estimated Pay Range

$266,000.00 - $346,000.00

Company Description

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.