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# Software Quality Engineering Lead

- **Company:** Johnson & Johnson
- **Location:** Santa Clara, CA, United States (Remote available)
- **Experience:** Expert
- **Salary:** $187,000.0 - $207,000.0
- **Contract:** Permanent contract
- **Skills:** Data Analysis, Software Quality, Software Product Management, Software Tools, Software Requirements Analysis, Verification and Validation (Software), Software Technical Review, Information Technology
- **Published:** July 1, 2026
- **Apply:** http://hbcunetwork.com//cgi-bin/jobs/searchJobs.cgi?job_id=35050471

## About the Role

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.

## Description

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.


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