Product Software Staff Quality Engineer

  • Company: Johnson & Johnson
  • Posted: March 03, 2017
  • Reference ID: 0424161116-en-us

Staff Software Quality Engineer (Quality Engineer 4 – PAY GRADE XX)


The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Staff Product Product Software Quality Engineer to be located Irvine. .


The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.


Advanced Sterilization Products (ASP), division of Ethicon, Inc., a Johnson & Johnson company, truly makes a difference by Protecting Lives against Infection. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions. Learn more about Advanced Sterilization Products at




Job Scope


Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.  Act’s as a subject matter expert in routine Quality Engineering and scientific matters. Develops and leads key strategic Quality Engineering/scientific initiatives throughout the organization.


Key Technical Responsibilities*


• Demonstrates high level of proficiency in applying established tools and methods to identify and realize new product or process introductions.

• Resolves and seeks consensus across affected business areas.

• Leads, contributes to assessments of product design.

• Leads, contributes to the utilization of, and/or develops innovative applications for various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis).

• Leads, and/or contributes to, root cause investigations using various problem solving techniques and tools (Ex. K-T analysis), and assesses effectiveness of corrective actions.

• Leads, and/or contributes to, the development of new detection systems by developing optimal methods for conducting software system development, process, and product qualifications/validations.

• Collaborates with senior technical leaders to develop best practices for system/software development methods.

• Mentors others in various technical capabilities.

• Leads or participates in technical reviews as appropriate

• Recommends issue resolution to senior management for significant capability and compliance issues.





• Bachelor’s degree (or equivalent) in Engineering (software, computer, computer science or electrical) AND 5 or more years of relevant experience OR Graduate degree AND 3 or more years of relevant experience.

• ASQ CQE, CQM, CQA; Process Excellence yellow, green or black belt optional




• Experience working in a regulated environment (Medical Device, Aerospace, etc.). This includes knowledge of, and experience with, applicable standards, GxP requirements and applicable regulations.

• Development experience with any or all: imbedded product software, ATE, customer/product data management, product connectivity

• Strong knowledge of system development methodologies and software program metrics.

• Experience with system/software Quality Engineering methods, techniques and principles.

• Thorough understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 820 and 21 CFR Part 11.

• Thorough knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management

• Experience with cyber security and data integrity requirements, methods and implementation

• Experience managing projects, and demonstrating project leadership abilities.

• Experience with a proven track record of implementing appropriate risk mitigation w/in-depth knowledge of ISO 14971 Risk Management and IEC 62366 Software Development Processes.

• Experience with GxP data collection

• Demonstrated ability to perform “hands on” troubleshooting and problem solving.

• Working knowledge of failure investigation processes, computer code static analysis methods and tools.

• Clear and effective communicator (presentation, technical writing, verbal)




Specialized Q&C Competencies


• Production and Processing Systems

• Qualification and Validation

• Product Design Support

• Quality Statistics, Data Analysis and Tools

• Product Control and Disposition

• Product Development Support

• Product Risk Management Support

• Predictive Analytics / Software Reliability

• Customer focus

• Results and performance driven

• Sense of urgency

• Collaboration and teamwork

• Self-awareness and adaptability


Primary Location
United States-California-Irvine
Advanced Sterilization Products (ASP)
Job Function
Quality (Eng)

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