Software Quality Engineering Lead

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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

New Brunswick, New Jersey, United States of America, Santa Clara, California, United States of America

Job Description:

Employer:

Auris Health, Inc.

Job Title:

Software Quality Engineering Lead

Job Code: A

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, ISO
14971, IEC
62304), 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 7/8/2026.

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  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…