高级资深软件高级质量工程师
Senior Staff Software Advance Quality Engineer
工作灵活性：远程或混合办公或现场办公
是时候加入Stryker了！
为什么加入我们
在这一职位中，你将帮助塑造不断扩展的数字化和连接解决方案组合中的软件质量实践。你将影响软件团队如何在开发过程中融入质量、合规性、安全性和风险管理，同时建立可扩展的流程，以支持创新和高效的交付。
Stryker正在寻找一名高级软件质量保证工程师，以支持我们的数字平台中心。在此职位中，你将与软件研发团队合作，建立、实施并改进针对数字化、连接型、SaaS和基于云的产品的质量流程。
你将在整个软件开发生命周期中提供质量体系指导，支持审计和合规准备，并将监管和行业要求转化为实际、可扩展的流程。你将与研发、产品安全、隐私、法规事务、IT、运营和质量团队合作，以实现高效且合规的软件交付。
这不是一个软件测试或测试执行的职位。该职位专注于软件质量体系、SDLC治理、风险管理、审计准备和流程改进。
你将负责
软件质量体系和流程领导
- 作为软件、SaaS、基于云和连接产品的软件质量和合规性主题专家。
- 指导软件研发团队遵循适用的质量管理体系流程、程序和文档要求。
- 开发、维护并改进软件质量流程、操作指南、模板和指导文件。
- 识别流程缺口，并在软件开发生命周期中推动持续改进计划。
- 将监管、质量、安全和合规要求转化为实际的开发流程。
- 建立可扩展的质量实践，以支持合规且高效的软件交付。
- 评估新兴法规和标准，并确定其对软件开发流程的影响。
软件生命周期和风险管理
- 在需求、设计、开发、变更控制、发布、维护和退役活动中提供质量指导。
- 参与设计评审、风险评估、变更评估和发布准备评审。
- 确保软件质量和合规性风险被识别、评估、记录并得到适当处理。
查看英文原文
Work Flexibility: Remote or Hybrid or OnsiteIt’s Time to Join Stryker!
Why Join Us
In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery.
Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Platform Hub. In this role, you will partner with software R&D teams to establish, implement, and improve quality processes across digital, connected, SaaS, and cloud-based products.
You will provide quality-system guidance throughout the software development lifecycle, support audit and compliance readiness, and translate regulatory and industry requirements into practical, scalable processes. You will collaborate with R&D, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality to enable efficient and compliant software delivery.
This is not a software testing or test-execution role. This position focuses on software quality systems, SDLC governance, risk management, audit readiness, and process improvement.
What You Will Do
Software Quality Systems and Process Leadership
- 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.
Software Lifecycle and Risk Management
- 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.
Audit and Compliance Readiness
- 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.
Cross-Functional Leadership
- 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.
What You Need
- 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.
Preferred Qualifications (You Do Not Need to Have All of These)
- Master’s degree or another advanced technical degree.
- Professional experience in software engineering or development before transitioning into software quality, compliance, or quality systems.
- 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.
United States of America Pay Ranges:
- Puerto Rico: $102,600 - $171,000 USD Annual
- USN: $118,000 - $196,700 USD Annual
- US5: $123,900 - $206,500 USD Annual
- US10: $129,800 - $216,400 USD Annual
- US15: $135,700 - $226,200 USD Annual
- US20: $141,600 - $236,000 USD Annual
- US30: $153,400 - $255,700 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.Originally posted on Himalayas