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Digital NPD Quality Manager
HybridFull-timeQA & Test AutomationMedical Devices
Lead quality and compliance activities for digital product development within a medical technology organization. Partner with R&D, Operations, and cross-functional teams to ensure digital and software-enabled medical device solutions meet quality, regulatory, cybersecurity, and privacy requirements.
Responsibilities
- Lead quality and compliance activities for digital product development programs
- Ensure design control compliance throughout the product lifecycle
- Manage Design History Files and conduct quality reviews and audits
- Provide quality oversight for cloud-based and software-enabled medical devices
- Review quality and compliance requirements for external partners and subcontractors
- Lead risk assessments, FMEA reviews, and mitigation planning
- Participate in design reviews and product release approvals
- Ensure compliance with software development, cybersecurity, privacy, and quality system requirements
- Lead internal audits and support external regulatory inspections
- Drive investigations, CAPA activities, defect reviews, and issue escalation
- Improve quality processes and procedures
- Mentor Quality Engineers and present quality metrics, risks, and project updates to senior leadership
Requirements
- Bachelor’s degree in engineering, quality, statistics, computer science, or a related technical field
- Several years of Quality Engineering or Quality Management experience in a regulated industry
- Experience supporting New Product Development programs
- Strong knowledge of design controls, risk management, and quality systems
- Experience working cross-functionally with R&D and Operations teams
- Fluent written and spoken English
Nice to have
- Medical device industry experience
- Experience with software, cloud-based, or digital health solutions
- Knowledge of cybersecurity and privacy requirements for connected medical products
- Experience with ISO 27001 and software quality standards
- Experience leading audits, CAPAs, and quality improvement initiatives
Benefits
- Hybrid work model
- Up to 15% domestic and international travel