Johnson & Johnson MedTech · 17 hours ago
Head of Quality & Compliance, Monarch Platform
Santa Clara, CA
Full-time
Onsite
Director/Executive
$200K/yr - $344K/yr
15+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, seeking a Head of Quality and Compliance for the Monarch platform. This role is responsible for overseeing Quality and Compliance across product design, manufacturing, and operations, ensuring alignment with organizational objectives and regulatory standards.
Hospital & Health Care
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
Qualification
Required
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
Ability to lead others, support talent development, and foster high-performing, accountable teams is required
Preferred
A master's degree is preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Company’s long-term incentive program
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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