Johnson & Johnson Careers

Staff Software Quality Engineer

Irvine, California
Quality (Eng)

Job Description

Requisition ID: 0027180503

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Staff Software Quality Engineer aligned to Advanced Sterilization Products (ASP), division of Ethicon, located in Irvine, CA.

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.

ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies.  The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers and communities.  ASP is based in Irvine, California with offices around the world.  For more information, please visit or follow us at

You the, Staff Software Quality Engineer will:
  • Apply 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.
  • Develop and lead key strategic Quality Engineering/scientific initiatives throughout the organization.
  • Support projects and assure compliance with software procedures, identify task dependencies, guide teams on appropriateness of the development life cycle, and assure development and maintenance efforts are effective and compliant.                                                                                               Provide software quality engineering principal expertise, both external (Regulations) and internal (J&J, MD&D and ASP standards and procedures)    
  • Provide training to software development teams, staff, contractors and business partners on ASP software quality engineering procedures.     
  • Lead compliance and risk management activities for software projects or software portion of systems projects.
  • Continually improve software quality engineering processes. Improve technical expertise and understanding of regulatory requirements
  • Assure that robust, reliable and compliant systems are transferred to users.
  • Assure that project software change control is compliant with procedures
  • Implement systems to address changing regulations.  
  • Represent SWQE function during regulatory inspections.
  • Recommend issue resolution to senior management for significant capability and compliance issues. 
  • Resolve and seeks consensus across affected business areas.
  • Ensure that all applicable Quality System Regulation, including FDA and ISO (i.e. QSR 21, CFR 820, ISO13485, IEC 02304, ISO 14971.), security, records retention, Sarbanes-Oxley laws and applicable statutory/regulatory (e.g. FDA and ISO) compliance are considered and emphasized in all computer Systems Validation plans and actions
  • Ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes.
  • Establish and recommend changes to standard operating procedures in all areas related to Computer Systems Validation and be responsible for providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure project teams are aligned with current regulatory requirements, standards, and current industry trends (FDA QSR 21 CFR 820 / ISO13485 quality system requirements
  • Ensure and/or develop appropriate methodologies, policies and procedures to deliver business solutions consistent with the company and department Vision and Mission, will lead continuous improvement of the Software Development Lifecycle Management process and clarify business needs and turn them into solution designs and will serve as the technical subject matter and expert and communicates to auditors and investigators on Computer Systems Validation process 
  • Serve as the technical expert for the organization (worldwide) in the application of Software Development Lifecycle Management advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product).                    

  • A Bachelor’s degree in Engineering (software, computer, computer science or electrical or related discipline is required.
  • A minimum of 6 years of related work experience is required.
  • A Graduate degree is preferred.  
  • A Degree in Software Engineering or Computer Science is preferred. 
  • ASQ CQE, CQM, CQA; Process Excellence yellow, green or black belt is preferred.  
  • Experience working in a regulated environment (Medical Device, Aerospace, etc.) is preferred.
  • Development experience with any or all: imbedded product software, ATE, customer/product data management, product connectivity is preferred. 
  • Strong knowledge of system development methodologies and software program metrics is preferred.
  • Experience with system/software Quality Engineering methods, techniques and principles is preferred.
  • Thorough understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 820 and 21 CFR Part 11 is preferred.
  • Thorough knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management is required.
  • Experience with cyber security and data integrity requirements, methods and implementation is preferred.
  • Experience managing projects, and demonstrating project leadership abilities is preferred.
  • 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 is preferred.
  • Leadership ability in developing achievable high-quality computer Systems Validation in partnership with various departments, such as R&D, Operations, Service etc. and managing the implementation and execution of these SDLC goals is strongly preferred.  
  • Strong knowledge of Product Software Lifecycle Development process is required. 
  • A working knowledge of Microsoft office products (MS Word, Excel) and other Testing Software tools is required.    
  • Strong working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise is required. 
  • Extensive Quality Engineering experience with working knowledge of product design verification, as well as product and project validation activities is required.
  • Demonstrated competence in change management is preferred.
  • This position will be located in Irvine, CA and may require up to 10% domestic and/or international travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-California-Irvine
Ethicon Inc. (6045)
Job Function
Quality (Eng)
Requisition ID