Senior Software Quality Engineer

Johnson & Johnson; Santa Clara (CA); On-site; USD 105,000 - 170,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Senior Software Quality Engineer for their Santa Clara location. You will play a pivotal role in advancing the MONARCH surgical robotics platform by ensuring quality compliance throughout the software development lifecycle. The ideal candidate will have a robust background in quality assurance, particularly in regulated industries, and will work collaboratively with cross-functional teams to uphold high standards of product quality and reliability.

Benefits

Annual performance bonus

Medical, dental, and vision insurance

401(k) retirement savings plan

Vacation time up to 120 hours per year

Sick time up to 40 hours per year

Qualifications

• 6 years’ experience with quality assurance focused on software testing.
• 3 years’ experience in a quality role within regulated industries.
• Strong knowledge of software validation standards.

Responsibilities

• Review all project software deliverables and ensure compliance with standards.
• Provide quality representation during software problem resolution.
• Support internal and external audits.

Skills

Communication

Problem Solving

Analytical Skills

Education

Bachelor of Science degree in Electrical, Computer Science or related engineering field

Tools

IEC 62304

FDA’s General Principles of Software validation

ISO 13485

21 CFR 820

MDR

Job description

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 MedTech, 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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

About MedTech

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 https://www.jnj.com/medtech

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

Our team advances the MONARCH surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’ skills.

The Senior Software Quality Engineer is responsible for supporting product quality and reliability ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices. Working closely with multi-functional teams this individual will act as an authority for both product and non-product software quality throughout the development lifecycle. The individual reviews and assesses software activities (e.g. user needs, software development plans, software requirements, software architecture and design, product security, software verification and validation) to ensure that they comply with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, software problem resolution and both Internal and External Audits.

Key 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.

Qualifications

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

Other:

• 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 VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$105,000 to $169,050

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be 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. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year