Head of Quality & Compliance, Monarch Platform at Johnson & Johnson

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTechIndustries

Requirements

Leadership experience in Quality & Compliance, particularly in medical devices or healthcare innovation (e.g., robotics, digital surgery)
Expertise in end-to-end quality processes: Design & Development, Manufacturing/Operations, Quality & Compliance, Post-Market Surveillance
Strong knowledge of Quality Management Systems (QMS), risk management, design controls, supplier controls, process validation, and regulatory compliance (e.g., FDA, Notified Bodies)
Ability to lead and manage teams of quality associates, engineers, and managers
Experience driving audits/inspections, CAPA programs, and quality KPIs
Strategic partnership skills with cross-functional teams (R&D, Supply Chain, Manufacturing, Clinical, Regulatory, Service, Marketing)
Capability to develop and implement multi-year Q&C strategies aligned with business growth
Location: Santa Clara, California (full-time)

Responsibilities

Drive exceptional Quality and Compliance, focusing on customer safety, product design, manufacturability, and reliability across Product Development, Operations, Distribution, and Commercial processes
Provide direct quality influence on components, assemblies, final products, suppliers, R&D, production builds, and product release for testing/commercialization
Lead quality & compliance requirements for risk management, design concepts/specifications, design for quality/manufacturing, process/technology development, verification/validation, and QMS processes
Partner with cross-functional teams (R&D, Supply Chain/Manufacturing, Clinical/Medical Affairs, Regulatory, Service, Marketing) for new product development, manufacturing, delivery, and market releases
Implement and maintain a compliant, scalable, agile, effective QMS; transform RAD QMS processes to fit business needs
Collaborate with Global VP Q&C Robotics to develop multi-year Q&C strategy for Monarch and RAD; manage strategic initiatives
Ensure compliance and accountability for QMS, including execution of Internal/External Audit programs, managing audit/inspection outcomes with Notified Bodies/FDA, oversight of CAPA Program, and quality KPIs
Act as strategic thought partner with Monarch business leaders, linking Quality objectives to business strategy and implementing QMS policies/strategies for regulatory compliance, customer safety, and satisfaction

Skills

Key technologies and capabilities for this role

Quality ManagementRegulatory ComplianceRisk ManagementDesign ControlsManufacturing QualitySupplier ControlsPost-Market SurveillanceProduct VerificationValidationProcess Development

Questions & Answers

Common questions about this position

Is this a remote position or does it require being in the office?

This role is based in Santa Clara, California, and requires being located there.

What salary or compensation does this role offer?

This information is not specified in the job description.

What key skills and experience are required for the Head of Quality & Compliance role?

The role requires leadership in quality and compliance, expertise in risk management, design controls, manufacturing processes, supplier controls, post-market surveillance, and Quality Management Systems, along with the ability to partner cross-functionally.

What is the reporting structure and team for this position?

The role reports directly to the Global VP of Q&C Robotics and Digital Surgery and involves leading a team of quality associates, engineers, and managers.

What makes a strong candidate for this Head of Quality & Compliance position?

A strong candidate will have proven leadership in end-to-end quality and compliance for medical devices, experience driving scalable QMS, and the ability to influence cross-functional teams in R&D, manufacturing, and commercialization.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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