Vice President, Product Design Quality
New
I
iRhythm TechnologiesMedical Devices
Remote - USFull-TimeVp
Salary266,000 - 346,000 USD per year
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Job Details
- Experience
- 15+ years of progressive leadership experience
- Required Skills
- Risk Management
Requirements
- 15+ years of progressive leadership experience in Medical Device Quality and/or Design Quality.
- Expertise in design controls, design transfer, and risk management.
- Significant experience leading FDA responses, remediation efforts, and inspection readiness activities.
- Deep understanding of FDA regulations, ISO 13485, ISO 14971, and global regulatory requirements.
- Experience supporting connected medical devices and Software as a Medical Device (SaMD) teams.
- Demonstrated success building, developing, and leading high-performing teams.
- Proven ability to conduct risk-benefit analyses and lead cross-functional stakeholders.
- Cardiovascular medical device experience (preferred).
- Experience supporting AI-enabled products or digital health technologies (preferred).
Responsibilities
- Lead and scale the Design Quality organization, including hardware, software (SaMD), and risk management teams.
- Ensure quality and regulatory considerations are embedded in product portfolio strategy, development, and lifecycle management.
- Establish Design Quality as a strategic business partner to R&D, Clinical, Regulatory, and Operations teams.
- Drive transformation and harmonization of Design Quality processes within the Quality Management System (QMS).
- Lead FDA inspections and Notified Body audits, including managing responses to FDA warning letters.
- Oversee enterprise product risk management to ensure alignment with ISO 14971.
- Establish metrics, dashboards, and governance mechanisms to monitor design process effectiveness.
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