Job Summary:
The company is seeking an experienced Principal Software Quality Engineer to support software quality assurance and regulatory compliance initiatives for healthcare technology products. This role will focus on software development lifecycle execution, testing oversight, quality system compliance, and risk management activities to ensure delivery of high-quality, compliant software solutions. The ideal candidate will bring strong expertise in software quality engineering, validation, and cross-functional collaboration within a regulated environment.
Key Responsibilities:
• Lead software quality assurance activities across the full software development lifecycle from requirements through release.
• Review, author, and approve software quality deliverables including validation protocols, test documentation, and defect records.
• Execute and oversee manual and automated testing activities including functional, regression, integration, and user acceptance testing.
• Monitor software defect lifecycle activities and ensure timely documentation, tracking, resolution, and closure.
• Ensure software products and related processes comply with applicable quality system procedures and regulatory standards.
• Evaluate product quality risks and prepare risk management documentation to support product safety and effectiveness.
• Collaborate with software development, validation, cybersecurity, and quality teams to drive compliant project completion.
• Provide technical guidance on quality assurance processes, SDLC compliance, and testing best practices.
• Support continuous improvement initiatives related to software quality systems, testing workflows, and compliance readiness.
• Contribute to project planning, milestone execution, and timely delivery of quality objectives.
• Train and mentor junior quality professionals and provide oversight on assigned quality activities.
• Participate in audits, inspections, and internal reviews to ensure sustained quality compliance.
Required Qualifications:
• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Software Engineering, or a related technical discipline.
• Minimum 5 years of experience in Software Quality Assurance, Quality Engineering, or related quality/compliance functions.
• Strong experience executing software development lifecycle activities and software defect lifecycle management.
• Hands-on experience with manual and automated software test execution including functional, regression, and user acceptance testing.
• Proven ability to review and approve software quality documentation and validation deliverables.
• Strong understanding of regulated quality systems and compliance-driven software processes.
• Excellent analytical, documentation, organizational, and cross-functional communication skills.
• Ability to quickly adapt to existing systems, tools, and established quality workflows.
• Demonstrated ownership mindset with ability to independently drive assignments through completion.
Preferred Qualifications:
• Prior experience in healthcare, medical device, diagnostics, or other regulated industries.
• Experience with Application Lifecycle Management tools.
• Knowledge of cloud-based software applications.
• Familiarity with cybersecurity standards and software security validation.
• Experience working within Agile software development methodologies.
• Previous experience supporting software quality initiatives within highly structured enterprise environments.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $30/hr to $42/hr