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 www.aspjj.com/us
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