Johnson & Johnson MedTech
Head of Quality & Compliance, Monarch Platform
Johnson & Johnson MedTech, Santa Clara, California, us, 95053
Head of Quality & Compliance, Monarch Platform
Johnson & Johnson MedTech
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.
Responsibilities
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.
Qualifications
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.
Location & Travel
Base location: Santa Clara, California. On‑site presence required; responsibilities span multiple sites.
Travel: up to 10% (potentially higher).
Relocation assistance available.
Compensation Base salary range: $200,000 – $343,850 annually. Long‑term incentive and benefit programs available.
Benefits Medical, dental, vision, life insurance; 401(k) with matching; long‑term incentive; paid vacation, sick time, holiday, family leave, and parental leave.
EEO Statement Johnson & Johnson is an Equal Opportunity Employer; we celebrate diversity and inclusion.
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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.
Responsibilities
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.
Qualifications
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.
Location & Travel
Base location: Santa Clara, California. On‑site presence required; responsibilities span multiple sites.
Travel: up to 10% (potentially higher).
Relocation assistance available.
Compensation Base salary range: $200,000 – $343,850 annually. Long‑term incentive and benefit programs available.
Benefits Medical, dental, vision, life insurance; 401(k) with matching; long‑term incentive; paid vacation, sick time, holiday, family leave, and parental leave.
EEO Statement Johnson & Johnson is an Equal Opportunity Employer; we celebrate diversity and inclusion.
#J-18808-Ljbffr