Senior Software Quality Engineer

Overview

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Product Development
Job Sub Function: R&D Software/Systems Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Santa Clara, California, United States of America

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

Johnson & Johnson is recruiting for a Senior Software Quality Engineer, located in Santa Clara, CA.

• Review all project / program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
• Provide direction and leadership for verification and validation of non-product software, products software, software tools and components.
• Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation. Collaborate with project / program teams to ensure software deliverables comply with RADS procedures, global ISO standards (ISO 13485, ISO
  14971, IEC
  62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Medical Device Regulation (MDR), and applicable guidance).
• Provide Quality representation during software problem resolution.
• Participate in technical design reviews and project phase reviews.
• Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.
• Identify and implement changes to ensure the continued suitability and effectiveness of the quality management system using quality policy, quality objectives, audit results, analysis of data, etc.
• Support internal audits and external audits by regulatory agencies, as required.

Required:

• Bachelor of Science degree in Electrical, Computer Science or any related engineering field.
• 6 years’ experience with quality assurance with a focus on software testing, design control of software development, software verification and validation.
• 3 years’ experience in a quality role within the medical device, aerospace/defense or similarly regulated industry.
• Strong verbal and written communication skills; ability to present issues, plans and objectives.
• Excellent organizational, problem solving, and analytical skills
• Working knowledge of IEC 62304, FDA’s General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDR.
• Ability to lead cross-functional teams in problem solving and risk analysis activities.
• Ability to manage priorities and workflow; versatility, flexibility, and a willingness to work within constantly evolving priorities.

Preferred:

• Masters or Advanced Degree
• ASQ certification as a Software Quality Engineer

• Ability to travel up to 10% domestic and international is required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under…