Digital NPD Quality Manager

About the role

We are seeking an experienced Digital NPD Quality Manager to lead quality and compliance activities for digital product development within Johnson & Johnson’s Biosense Webster innovation organization. The role partners with R&D, Operations and cross‑functional teams to ensure digital healthcare solutions meet all quality, regulatory, cybersecurity and privacy requirements throughout their lifecycle.

Key responsibilities

• Lead quality and compliance initiatives for digital product development programs.
• Ensure design control compliance across the product development lifecycle.
• Manage and maintain Design History Files (DHF) and conduct quality reviews and audits.
• Collaborate with R&D, Operations and external partners to support development and commercialization of digital solutions.
• Provide quality oversight for cloud‑based and software‑enabled medical device products.
• Review and approve quality and compliance requirements for subcontractors and external partners.
• Drive risk management activities, including risk assessment and mitigation.

Required profile

• Proven experience in quality and regulatory compliance for digital medical device development.
• Strong knowledge of design control, DHF management and risk management processes.
• Ability to work effectively with cross‑functional teams and external partners.
• Excellent analytical and problem‑solving skills.

Required skills

• Design History File (DHF) management
• Risk Management (e.g., ISO 14971)
• Regulatory compliance for medical device software (e.g., IEC 62304)
• Quality Management System (QMS) implementation
• Knowledge of cybersecurity and privacy requirements for digital health solutions