Head of Quality & Compliance, Monarch Platform

Johnson & Johnson • Santa Clara, CA

49d • Onsite

About The Position

Robotics and Digital Surgery, a division of Johnson & Johnson Medtech Surgery Group, seeks a Head of Quality and Compliance for the Monarch platform. The role oversees Design & Development, Manufacturing/Operations, Quality & Compliance, and Post Market Surveillance, reporting to the Global VP of Q&C Robotics and Digital Surgery at the Santa Clara campus in California. This role is responsible for overseeing Quality and Compliance, with a focus on product design, manufacturability, and reliability throughout Product Development, Operations, Distribution, and Commercial processes. The position involves collaboration with teams including quality associates, engineers, and managers, who carry out product quality and compliance tasks across areas such as risk management, product design, manufacturing process and technology development, product verification and validation, large-scale manufacturing, supplier management controls, quality control and compliance, post-market surveillance, project planning and transformation, and related Quality Management System activities. The Head of Monarch Q&C partners with cross-functional teams to drive product innovation and meet customer needs. They lead the Monarch Quality & Compliance team, maintain a scalable QMS, and collaborate with the Global VP Q&C Robotics on strategy and growth. Key duties also include overseeing audits, CAPA management, post market surveillance, and quality KPIs, while improving processes for reliability and scalability.

Requirements

• A bachelor’s degree in biomedical or mechanical or electrical or relevant engineering discipline is required; a master's degree is preferred.
• Candidates must have at least 15 years of experience, including a minimum of 12 years in medical devices, with comprehensive knowledge of Design Controls, Design Verification and Validation, and Design Transfer processes.
• Five years of experience working with large medical equipment devices, embedded software, and hardware are also needed.
• Must have a minimum of 5 years as a quality director or higher in a quality function related to Design and Development, covering End-to-End Product Quality and Compliance within the Medical Device industry.
• Demonstrated experience with product lifecycle management, taking products from concept through manufacturing and commercialization, and scaling up large medical device equipment is necessary.
• Experience with AI/ML-enabled device development, software lifecycle management, and digital health quality integration is essential.
• Knowledge of Design Controls, Statistical Methods, Quality Engineering and Management, Risk Management, and familiarity with supply chain, operations, and post-market surveillance is required.
• Successful history leading FDA inspections, ISO certification audits, and MDSAP assessments, with a strong understanding of global regulatory requirements.
• Proficiency in 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, ISO 27001, and EU MDR compliance frameworks are expected.
• Practical experience with risk management and electrical safety standards such as EN ISO 14971 and IEC 60601 is required.
• Experience implementing scalable QMS architectures and digital quality systems for complex, multi-component robotic platforms.
• Background in Human Product Factors and Usability Engineering, with responsibilities that include supporting Product Reliability principles and product testing.
• Ability to lead others, support talent development, and foster high-performing, accountable teams is required.
• This position is based at our Santa Clara Robotics Campus in California and requires on-site presence.
• Responsibilities will extend across multiple locations.
• Supervise Managers and individual contributors across multiple sites.
• Manage current organizations with more than 50 + individuals.

Nice To Haves

• Experience with cybersecurity requirements, as well as optical, visualization, and imaging products, is highly preferred.
• Experience in designing, developing, or manufacturing surgical robotic or assistive robotic systems is preferred.

Responsibilities

• Collaborate with Monarch platform business leaders to formulate business strategies and ensure that organizational objectives, strategies, and quality standards are consistently aligned.
• Focus on implementing Quality Management System policies to meet customer safety, satisfaction, and regulatory requirements.
• Emphasize benchmarking and the dissemination of best practices both within Johnson & Johnson and externally to enhance organizational competitiveness.
• Work with Operations and Process Excellence to drive customer improvements by aligning risk management, process transformation, and business priorities.
• Build and strengthen Quality and Compliance skills, focusing on technology expertise and leadership with full accountability.
• Help define the strategy for quality and compliance, aligning customer and market needs with product development and manufacturing to meet Monarch platform and Robotics business goals.
• Acts as a Strategic Integrator—connecting quality strategy with product innovation, manufacturability, and business outcomes.
• Demonstrates Transformational Leadership—able to scale organizations, implement accountability models, and elevate quality as a competitive advantage.
• Serves as a trusted Enterprise Influencer, collaborating across J&J MedTech and external agencies to drive proactive compliance and regulatory engagement.
• Embodies Proactive Risk Leadership by identifying and mitigating potential compliance or design risks early in the development cycle.
• Leads with technical credibility and executive presence, inspiring confidence across engineering, operations, and executive teams.
• Builds and mentors high-performing quality teams, fostering empowerment, cross-functional collaboration, and continuous improvement.
• Manage influence, collaboration, and leadership of cross-functional teams to reach risk-based decisions in complex capital medical device product reviews.
• Uses analytical skills and innovative Quality Engineering methods to solve problems and meet business goals.
• Demonstrates a strategic and goal-oriented approach in formulating and implementing mid to long term functional strategies and transformational initiatives.
• Show leadership and team development skills in line with Johnson & Johnson’s Credo.
• Lead the development and implementation of top-tier quality management and engineering systems to support product life cycle management, emphasizing early defect prevention and detection for optimal customer satisfaction.
• Promote collaboration and knowledge sharing among product development, operations, manufacturing, contract manufacturers, and suppliers.
• Mentor engineers and leaders across R&D, New Product Development, and Operations to build and maintain a robust talent pipeline.
• Show understanding of both current and developing regulations and practices to assist clinical research teams in first-in-human studies, as well as meet the requirements for sponsors involved in clinical investigations of medical devices.
• Collaborate with quality and regulatory teams to maintain compliance with current international quality systems and product standards, including requirements related to human factors, cybersecurity, and product security.
• Assist with regulatory submissions by analyzing data, interpreting requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA, EU MDR, and other relevant regulations.
• Collaborate with Johnson & Johnson teams to implement standard processes across Robotics.
• Ensure that Quality and Compliance are involved as partners, provide guidance in developing talent, maintain trust, share accountability, and apply best practices to enhance competitiveness.

Benefits

• employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees