Johnson & Johnson · 8 hours ago
Senior Software Quality Engineer
Santa Clara, California, United States of America
Full-time
Hybrid
Mid, Senior Level
$125K/yr - $201K/yr
6+ years expJohnson & Johnson is a leading company in healthcare innovation, dedicated to developing smarter and less invasive treatments. The Senior Software Quality Engineer will provide quality engineering support for the MONARCH™ surgical robotics platform, ensuring product quality and compliance throughout the development lifecycle.
Hospital & Health Care
Responsibilities
Review all project / program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports)
Provides 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 deliverable comply with RADS procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), 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
Identifies and implements any changes necessary to ensure and maintain 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
Qualification
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
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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