Manager - TQC New Health Platforms

Johnson & Johnson Services, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, TQC New Health Platforms in Raritan, NJ! Remote work options may be considered on a case-by-case basis and if approved by the Company.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

 With $94.9 billion in 2022 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Technology Quality and Compliance (TQ&C) leads the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions.

The Manager New Health Platforms ensures compliance of medical device software (SaMD) and product hosting infrastructure across the enterprise in accordance with internal policies, procedures and external regulations.

Responsible for supporting the project team through the day-to-day project activities under the supervision and direction of function head.

QUALITY OVERSIGHT

In conjunction with franchise quality assurance teams, provides quality oversight in support of engineering, release and post-market support activities for:

• SaMD - Standalone software medical devices (i.e. mobile, wearables, web applications)
• Hardware integrated solutions such as software enabled surgery systems (robotics)
• Digital manufacturing and 3D printing
• Medical device infrastructure, including IaaS and internal hosting of product software

This position is also responsible for providing regulatory compliance expertise and supporting any compliance related remediation efforts

Reviews/approves validation documentation work such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use

Ensures outstanding Inspection Readiness for Systems in software medical device portfolio, with the purpose of minimizing the risk of inspection observations to business systems/infrastructure