About This Role:About This Role:
The Staff Software Quality Engineer for Non-Product Software (NPS) will be the technical lead and subject matter expert (SME) responsible for the strategy, validation, and compliance of software tools used in the development and manufacturing of Medical Device.
This role ensures that all software applications supporting GxP business processes, software for tools and fixtures used for device manufacturing and processing, and software development/testing tools (e.g., Jira, Jenkins, GitHub) are validated according to the latest FDA Computer Software Assurance (CSA) guidance and ISO 13485 standards.
Essential Duties and Responsibilities:
- NPS Validation Strategy: Define and lead the Computer Software Assurance (CSA) strategy and validation master plans for new and existing non-product software.
- Risk Management: Apply risk-based testing methodologies to determine the appropriate rigor of validation for manufacturing, QMS, and development tools.
- Compliance Leadership: Ensure all NPS activities comply with 21 CFR Part 11 (electronic records/signatures) and ISO 13485.
- Documentation Oversight: Review, approve and occasionally author validation plans, software V&V, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols/reports.
- Tool Qualification: Lead the qualification of software-based test, manufacturing and processing equipment, automated data processing systems, and design tools.
- Cross-functional Collaboration: Partner with Manufacturing, IT, DevOps, and R&D teams to identify software needs and implement compliant workflows.
- Audit Readiness: Act as the technical lead for NPS during internal and external audits (FDA, ISO, Notified Bodies).
- Change Control: Manage software changes, updates, and patches via rigorous configuration management processes.
Experience and Minimum Qualifications:
- Typically requires a minimum of 12 years of related experience with a Bachelor's degree in Computer Science, Biomedical Engineering, or related technical field; or 8 years and a Master's degree; or equivalent work experience.
Knowledge, Skills and Abilities:
- Regulatory Knowledge: Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards and GAMP5.
- NPS Expertise: Demonstrated experience with validating custom software, tools and fixtures for device manufacturing and processing, DevOps toolchains (e.g., Jira, Git), test automation, and/or GxP applications supporting QMS and other GxP business processes.
- Technical Skills: Experience implementing risk-based testing (CSA) and automated testing tools.
- Soft Skills: Proven ability to lead cross-functional projects, mentor junior engineers, and communicate complex compliance requirements to technical and non-technical stakeholders.
- Preferred skills: Experience with SaMD / AI-enabled medical devices.
Work Environment / Other Requirements:
- iOC based
- Hybrid role with a minimum of 3 days on site
Location:Orange County
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range$127,000.00 - $165,000.00
