Senior Staff Cloud Software Quality, Compliance Engineer

🔥 13 hours ago

🏄 California, Florida, +4 more states – Remote

🏄 California – Remote 🐊 Florida – Remote 🗽 New York – Remote 🚗 Michigan – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $102.6k - $255.7k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Stryker

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1941

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Stryker is a global leader in medical technology, providing innovative products and services across the healthcare sector. With a presence in countries across the Americas, Asia Pacific, Europe, and the Middle East & Africa, Stryker offers a wide range of medical technologies, including orthopedic implants, surgical equipment, and advanced hospital devices. The company is committed to improving patient outcomes and healthcare efficiency. Stryker continues to expand its global reach, offering localized solutions to meet diverse healthcare needs worldwide.

📋 Description

• Serve as a software quality and compliance subject matter expert for software, SaaS, cloud-hosted, and connected products • Guide software R&D teams through applicable Quality Management System processes, procedures, and documentation requirements • Develop, maintain, and improve software quality procedures, work instructions, templates, and guidance documents • Identify process gaps and lead continuous-improvement initiatives across the software development lifecycle • Translate regulatory, quality, security, and compliance requirements into practical development processes • Establish scalable quality practices that support compliant and efficient software delivery • Assess emerging regulations and standards and determine their impact on software-development processes • Provide quality guidance throughout requirements, design, development, change control, release, maintenance, and retirement activities • Participate in design reviews, risk assessments, change assessments, and release-readiness reviews • Ensure software quality and compliance risks are identified, evaluated, documented, and appropriately addressed • Integrate quality and risk-management practices into Agile, DevOps, and CI/CD environments • Review software quality deliverables and provide clear, risk-based guidance to project teams • Support readiness activities for SOC 2, ISO 27001, HIPAA, FDA, and other applicable frameworks • Partner with control owners to ensure controls are implemented, maintained, and supported by objective evidence • Support internal and external audits through gap assessments, evidence collection, auditor interaction, and remediation • Lead or support investigations, root-cause analysis, corrective actions, and effectiveness monitoring related to software quality issues • Partner 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 • Resolve conflicts between development priorities, delivery timelines, and quality or compliance requirements • Promote the integration of quality, security, compliance, and risk management into software-development decisions

🎯 Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Engineering, Quality, or a related technical discipline is required • Six 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 leading audits, gap assessments, remediation activities, quality investigations, or corrective and preventive actions • Demonstrated ability to influence cross-functional teams, communicate complex requirements, and lead 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 (preferred) • Professional experience in software engineering or development before transitioning into software quality, compliance, or quality systems (preferred)

🏖️ Benefits

• Remote or hybrid or onsite work flexibility • Equal employment opportunity • 10% travel percentage