Johnson & Johnson Careers

Staff Software Quality Engineer

Santa Ana, California
Quality (Eng)

Job Description

Requisition ID: 1516190409

Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Staff Software Quality Engineer to be located in Santa Ana, CA. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. 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.

The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops.

Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.

The Staff Software Quality Engineer will provides quality leadership on new product project teams to ensure that medical devices and stand-alone software systems are being designed and validated to meet their intended use.  As a Staff Software Quality Engineer you will be subject matter expertise in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.

As a Staff Software Quality Engineer you will:

  • Provide direction to product and project teams from a Systems Development Life Cycle process and compliance perspective
  • Partner with R&D to define the white-box testing and black-box testing strategy
  • Ensure effective risk management by working with R&D to define risk control measures.
  • Lead/manage validation activities/projects
  • Develop testing strategies based on requirements and designs
  • Create/review and/or approves product/ equipment/ software validation documentation
  • Own CAPAs and drive root cause investigations
  • Review test case execution results and manage defects
  • Perform other related duties as assigned by management
  • Proactively examine processes to identify areas for review, change, or elimination


  • A minimum of a Bachelors degree in Computer Science, Software Engineering or related discipline with at least with 7 years of relevant experience is required
  • A Master’s degree is preferred
  • Experience supporting the testing of electro-mechanical systems that are controlled by software is required.
  • Excellent understanding of requirements management, configuration management, Software V&V, automated testing, defect management and software risk analysis is required
  • Experience in the Medical Device industry is preferred
  • Must have the ability to document system requirements, and understand system architecture and software designs is preferred
  • Must have had the experience designing test strategies based on software architecture, requirements and design is preferred
  • A background in programming is preferred
  • Knowledge of ISO 14971, 21 CFR 820, and 21 CFR 210 and 211 is preferred.
  • This position will be located in Santa Ana, CA and may require up to 10% domestic and/or international travel


Primary Location
United States-California-Santa Ana-
AMO US Holdings, Inc.. (6234)
Job Function
Quality (Eng)
Requisition ID