Software Quality Engineering Lead

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:
R&D Product Development

Job Sub Function:
R&D Software/Systems Engineering

Job Category:
People Leader

All Job Posting Locations:
US182 NJ New Brunswick - 100 Albany St

Job Description:

Employer:          Auris Health, Inc.

Job Title:            Software Quality Engineering Lead

Job Code:           A011.5804

Job Location:     New Brunswick , NJ

Job Type:            Full-Time

Rate of Pay:       $165,000 - $180,000/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.

May telecommute.

This job posting is anticipated to close on 7/30/2025.

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 id...