Software Quality Engineering Lead

Posted 4 Days Ago
Be an Early Applicant
Santa Clara, CA, USA
In-Office
187K-207K Annually
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Manage medical device software projects to ensure compliance with regulations. Review deliverables and provide direction for validation processes. Collaborate with teams to uphold standards and support audits.
Summary Generated by Built In

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 jnj.com.

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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Employer:       Auris Health, Inc.

Job Title:         Software Quality Engineering Lead

Job Code:        A011.5804.12

Job Location:  New Brunswick , NJ

Job Type:        Full-Time

Rate of Pay:     $187,000 - $207,000/year

Job Duties: Manage Direct Reports and oversees their medical device software projects to ensure compliance to local procedures and regulatory requirements. Review 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 company procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ 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.

Requirements: Employer will accept a Bachelor's degree in Computer Science, Engineering or related field and 8 years of experience in the job offered or in a Software Quality Engineering Lead-related occupation.

*Certified Software Quality Engineer (CSQE) certification required.

*Project Management Professional (PMP) certification required.

May telecommute.

This job posting is anticipated to close on 6/28/2026.

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

•           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

•           This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.

•           For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits



Required Skills:



Preferred Skills:

Skills Required

  • Bachelor's degree in Computer Science, Engineering or related field
  • 8 years of experience in software quality engineering
  • Certified Software Quality Engineer (CSQE) certification
  • Project Management Professional (PMP) certification

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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