Senior Staff Cloud Software Quality, Compliance Engineer

This is a fully remote position, open to applicants in California, +5 more states.

📋 Description

• Act as a subject matter expert in software quality and compliance for software, SaaS, cloud-hosted, and connected products.

• Guide software R&D teams through relevant Quality Management System processes, procedures, and documentation necessities.

• Create, maintain, and enhance software quality procedures, work instructions, templates, and guidance documents.

• Identify process deficiencies and spearhead continuous improvement initiatives across the software development lifecycle.

• Convert regulatory, quality, security, and compliance requirements into actionable development processes.

• Establish scalable quality practices that facilitate compliant and efficient software delivery.

• Evaluate emerging regulations and standards to assess their influence on software development processes.

• Provide quality guidance throughout the phases of requirements, design, development, change control, release, maintenance, and retirement activities.

• Engage in design reviews, risk assessments, change assessments, and release-readiness evaluations.

• Ensure that software quality and compliance risks are identified, assessed, documented, and properly addressed.

• Incorporate quality and risk management practices into Agile, DevOps, and CI/CD environments.

• Review software quality outputs and deliver clear, risk-based guidance to project teams.

• Assist with readiness activities for SOC 2, ISO 27001, HIPAA, FDA, and other relevant frameworks.

• Collaborate with control owners to guarantee that controls are implemented, maintained, and substantiated by objective evidence.

• Facilitate internal and external audits through gap assessments, evidence gathering, auditor interactions, and remediation efforts.

• Lead or assist in investigations, root-cause analysis, corrective actions, and monitoring of effectiveness related to software quality issues.

• Collaborate with Software Engineering, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality teams.

• Mentor and coach teams on quality system requirements, software risk management, and compliant development practices.

• Influence technical and business stakeholders without direct authority.

• Address conflicts between development priorities, delivery schedules, and quality or compliance obligations.

• Advocate for the integration of quality, security, compliance, and risk management into software development decisions.

⛳️ Requirements

• A Bachelor’s degree in Software Engineering, Computer Science, Engineering, Quality, or a related technical field is mandatory.

• A minimum of six years of professional experience in software quality, quality systems, software compliance, audit, or a related area supporting software, SaaS, cloud-based, or connected products is required.

• Proven experience in developing, implementing, maintaining, or enhancing software quality processes or procedures is essential.

• A strong understanding of the software development lifecycle, including change control, risk management, audit readiness, and Quality Management System processes is necessary.

• Experience collaborating with software development or R&D teams to implement or enhance software quality processes is required.

• Experience in supporting regulated software products, ideally within medical devices, digital health, healthcare technology, or another compliance-focused industry.

• Familiarity with SOC 2, ISO 27001, HIPAA, FDA software expectations, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485, or similar frameworks.

• Proficient knowledge of cloud platforms, DevOps, CI/CD, and software security controls.

• Experience leading audits, gap assessments, remediation efforts, quality investigations, or corrective and preventive actions.

• Demonstrated capacity to influence cross-functional teams, convey complex requirements, and lead process enhancements without direct authority.

• Professional certification such as CSQE, CQE, CQA, or an equivalent quality or compliance credential is preferred.

• A Master’s degree or another advanced technical degree is preferred.

• Prior professional experience in software engineering or development before transitioning to software quality, compliance, or quality systems is preferred.

🏝️ Benefits

• Flexibility to work remotely, in a hybrid model, or onsite.

• Commitment to equal employment opportunities.

• 10% travel requirement.