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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in software quality management, compliance, and process improvement within Agile and DevOps environments. Proficient in supporting regulated software products and conducting audits, gap assessments, and corrective actions.
Highest-signal resume keywords
Software Quality ManagementCompliance SupportAgile MethodologiesSOC 2, ISO 27001, HIPAAQuality Management System Processes
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Software Quality ProcessesRisk ManagementChange ControlAudit ReadinessRoot-Cause AnalysisCorrective ActionsProcess ImprovementSoftware Development LifecycleQuality InvestigationsEvidence Collection
Soft Skills
Cross-Functional CollaborationInfluencing StakeholdersCommunication Skills
Tools & Technologies
DevOpsCI/CDCloud PlatformsSoftware Security Controls
Certifications & Qualifications
CSQECQECQA
Industry Keywords
Regulated Software ProductsMedical DevicesDigital HealthHealthcare TechnologyCompliance-Driven Industry
Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- Guide software teams through applicable Quality Management System processes, procedures, and documentation requirements
- Develop and improve software quality procedures, work instructions, templates, and guidance documents
- Provide quality support across requirements, design, development, testing, release, operations, and software change-management activities
- Participate in design reviews, risk assessments, change assessments, and release-readiness activities
- Ensure software quality and compliance risks are identified, documented, and appropriately addressed
- Support quality practices within Agile, DevOps, and CI/CD environments
- Support SOC 2, ISO 27001, HIPAA, FDA, and other applicable compliance and audit-readiness activities
- Partner with control owners to ensure controls are maintained and supported by appropriate evidence
- Support internal and external audits through gap assessments, evidence collection, remediation, and audit preparation
- Participate in investigations, root-cause analysis, corrective actions, and effectiveness monitoring
- Partner with Software Engineering, Test Engineering, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality
- Identify process gaps and support improvements that strengthen consistency, efficiency, and compliance
- Translate quality, regulatory, security, and compliance requirements into practical development processes
- Influence cross-functional stakeholders and help resolve conflicts between development priorities and quality requirements
Requirements
What you’ll need- Bachelor’s degree in Software Engineering, Computer Science, Engineering, Quality, or a related technical discipline is required
- Four or more years of professional experience in software quality, quality systems, software compliance, audit, or a related field supporting software, SaaS, cloud-based, or connected products is required
- Experience developing, implementing, maintaining, or improving software quality processes or procedures is required
- Strong understanding of the software development lifecycle, including change control, risk management, audit readiness, and Quality Management System processes
- Experience partnering with software development or R&D teams to implement or improve software quality processes
- Experience supporting regulated software products, preferably within medical devices, digital health, healthcare technology, or another compliance-driven industry
- Experience with SOC 2, ISO 27001, HIPAA, FDA software expectations, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485, or comparable frameworks
- Working knowledge of cloud platforms, DevOps, CI/CD, and software security controls
- Experience supporting audits, gap assessments, remediation activities, quality investigations, or corrective and preventive actions
- Demonstrated ability to influence cross-functional teams, communicate complex requirements, and support process improvements without direct authority
- Professional certification such as CSQE, CQE, CQA, or an equivalent quality or compliance credential
- Master’s degree or another advanced technical degree is preferred
- Professional experience in software engineering or development before transitioning into software quality, compliance, or quality systems is preferred
Benefits
Comp & perks- Remote or hybrid or onsite work flexibility
- Equal opportunity employment
- 10% travel percentage