Head of Quality & Compliance, Monarch Platform

Head of Quality & Compliance, Monarch Platform

Johnson & Johnson Med Tech seeks a Head of Quality & Compliance for the Monarch platform at the Santa Clara, California campus.

As a senior leader, you will oversee Design & Development, Manufacturing/Operations, Quality & Compliance, and Post Market Surveillance, reporting to the Global VP of Q&C Robotics and Digital Surgery.

• Lead the Monarch Quality & Compliance team, maintain a scalable QMS, and collaborate with global leadership on strategy and growth.
• Oversee quality and compliance across product, operations, distribution, and commercial processes, ensuring regulatory and customer safety requirements.
• Drive audits, CAPA management, post‑market surveillance, and quality KPIs while improving processes for reliability and scalability.
• Partner with cross‑functional leaders to align risk management, process transformation, and business priorities.
• Champion proactive risk leadership and early defect prevention to support product innovation.

• Bachelor’s degree in biomedical, mechanical, electrical or related engineering; master’s preferred.
• 15+ years of experience, with minimum 12 years in medical devices and 5 years as a quality director or higher.
• Deep knowledge of Design Controls, Verification/Validation, Design Transfer, risk management, QMS, ISO 13485, IEC 62304, EU MDR, and related frameworks.
• Experience leading FDA inspections, ISO certification audits, IVD or MDSAP assessments, and certifications for complex robotic platforms.
• Proficiency in cybersecurity, human factors, and AI/ML‑enabled device development is highly preferred.
• Strong leadership, communication and talent‑development skills to build high‑performance quality teams.

• Base location:
  Santa Clara, California. On‑site presence required; responsibilities span multiple sites.
• Travel: up to 10% (potentially higher).
• Relocation assistance available.

Base salary range: $200,000 – $343,850 annually. Long‑term incentive and benefit programs available.

Medical, dental, vision, life insurance; 401(k) with matching; long‑term incentive; paid vacation, sick time, holiday, family leave, and parental leave.

Johnson & Johnson is an Equal Opportunity Employer; we celebrate diversity and inclusion.