高级质量保证工程师（手动与自动化）- 医疗科技
Senior QA Engineer (Manual & Automation) - MedTech
公司简介
在Bridgenext，我们构建增长操作系统。大多数企业已在收入系统上投入数百万美元，但仍未能实现预期的增长。他们拥有可用的工具，但没有能赢得市场的系统。我们帮助追求增长的公司填补这一差距，将分散的平台、孤立的团队和脱节的数据整合成一个统一的增长操作系统。我们不仅仅是一家技术公司或营销机构，而是一家全球数字咨询公司，拥有工程、数据、AI、创意等领域的专家。
我们的团队由相信工程影响力的专家组成，从将人们置于一切工作的核心开始。每位团队成员都直接塑造我们的工作、文化和价值观。对我们来说，最重要的是一个充满善意、尊重和成就感的环境，支持每个人。我们灵活且包容的文化为您提供自主权、资源和机会，以取得成功。
职位描述
我们正在寻找一位高度注重细节且经验丰富的高级QA工程师加入我们的MedTech团队。在此职位中，您将负责确保我们医疗保健和医疗技术软件解决方案的质量、安全性和合规性。
除了手动和自动化测试，该职位的关键重点包括严格的文档验证、流程合规性以及遵循GxP标准和医疗器械质量框架。
主要职责：
- 质量保证与合规（GxP重点）
- 按照GxP（GCP、GMP、GLP）标准对技术文档、测试计划、需求追踪矩阵（RTM）和验证协议（IQ/OQ/PQ）进行彻底的验证和审查。
- 确保所有软件开发和测试活动符合医疗监管标准（如FDA 21 CFR Part 11、ISO 13485、IEC 62304和HIPAA）。
- 参与监管合规审查、质量审计和标准操作程序（SOP）的验证。
- 为所有测试阶段和缺陷生命周期维护全面的可审计文档。
- 手动与自动化测试
- 为复杂的MedTech应用程序设计、开发和执行端到端测试策略、测试套件和测试用例。
- 建立并维护可维护、可扩展的自动化测试框架，用于API和UI测试（例如Cypress、Selenium、Playwright或Postman）。
- 在自动化测试不可行时执行手动功能、非功能、回归、集成和基于风险的测试。
查看英文原文
Company Overview
At Bridgenext, we engineer Growth Operating Systems. Most enterprises have spent millions on their revenue stack and still aren't seeing the growth they expected.They have tools that function, but no system that wins. We help growth-hungry companies close that gap by turning fragmented platforms, siloed teams, and disconnected data into one integrated Growth OS. More than a technology company or marketing agency, we're a global digital consultancy with experts in engineering, data, AI, creative and more.
Our teams are made up of experts who believe in engineering impact, starting with putting people at the center of everything we do. Every team member directly shapes our work, culture, and values. Nothing matters more to us than a kind, respectful, fulfilling environment that supports everyone. Our flexible, inclusive culture gives you the autonomy, resources, and opportunities to thrive.
Position Description
We are seeking a highly detail-oriented and experienced Senior QA Engineer to join our MedTech team. In this role, you will be responsible for ensuring the quality, safety, and compliance of our healthcare and medical technology software solutions.
Beyond hands-on manual and automated testing, a critical focus of this role involves rigorous documentation validation, process compliance, and adherence to GxP standards and medical device quality frameworks.
Key Responsibilities:
- Quality Assurance & Compliance (GxP Focus)
- Perform thorough validation and review of technical documentation, test plans, requirements trace matrices (RTM), and validation protocols (IQ/OQ/PQ) in accordance with GxP (GCP, GMP, GLP) standards.
- Ensure all software development and testing activities comply with healthcare regulatory standards (such as FDA 21 CFR Part 11, ISO 13485, IEC 62304, and HIPAA).
- Participate in regulatory compliance reviews, quality audits, and verification of standard operating procedures (SOPs).
- Maintain comprehensive audit-ready documentation for all testing phases and defect lifecycles.
- Manual & Automated Testing
- Design, develop, and execute end-to-end test strategies, test suites, and test cases for complex MedTech applications.
- Establish and maintain maintainable, scalable automated test frameworks for API and UI testing (e.g., Cypress, Selenium, Playwright, or Postman).
- Execute manual functional, non-functional, regression, integration, and risk-based testing where automated testing is not applicable or compliant.
- Identify, document, prioritize, and track software defects, ensuring root-cause analysis is performed in line with compliance procedures.
- Collaboration & Leadership
- Work closely with cross-functional teams including Software Engineers, Product Managers, Regulatory Affairs, and Quality Assurance Managers.
- Mentor junior QA engineers and advocate for quality-first, compliance-driven engineering practices across the team.
- Participate in Agile/Scrum ceremonies while maintaining the necessary balance between agile agility and strict regulatory documentation.
Workplace: Remote / Hybrid role in LATAM, preferably in Argentina
Must Have Skills:
- Experience: 5+ years of experience as a Quality Assurance Engineer, with a proven track record in both manual and automated testing within regulated environments
- Domain Knowledge: Solid background in the MedTech, HealthTech, Biotech, or Pharmaceutical industry
- GxP & Regulatory Expertise: Strong hands-on experience validating documentation and software under GxP guidelines, ISO standards (13485 / 14971), or FDA compliance regulations
- English Proficiency: Advanced to Fluent English (written and spoken). Seeking level C1/C2 level fluency. Ability to write clear, compliant technical documentation and articulate QA/regulatory concepts effectively to international stakeholders
- Automation Skills: Proven experience with modern test automation tools/frameworks (e.g., Selenium, Cypress, Playwright) and API testing tools (Postman, REST Assured)
- Documentation & Traceability: Exceptional skill in writing structured test plans, test cases, execution reports, and maintaining traceability matrices
- Tools: Experience using issue-tracking and QA management tools such as Jira, TestRail, Zephyr, or similar
Professional Skills:
- Excellent analytical and problem-solving skills
- Strong communication and interpersonal skills
- Ability to work effectively in a fast-paced, dynamic environment
- Ability to Lead and Guide Discussions with Business Partners
- Confident and Proactive Nature
- Ability to understand scope and ask the right questions
- Organized, detail and process oriented
- Proven ability to build, manage and foster a team-oriented environment
Bridgenext is an Equal Opportunity Employer
Originally posted on Himalayas