The Senior System Quality Engineer (SQE) ensures that software within a regulated medical device environment is verified to meet functional, safety, quality, and regulatory requirements across the entire product lifecycle. In this role, you will drive and contribute to planning, designing, executing, and documenting verification activities, working closely with development, systems engineering, product management, and quality/regulatory stakeholders. You will also play a key role in optimizing verification strategies, ensuring an efficient and sustainable product development.
Your Key Responsibilities
Verification Excellence
Plan, design, execute, and document manual and automated verification tests for medical device software
Ensure coverage of system requirements and risk controls in line with internal PLC processes
Deliver complete, traceable, and audit-ready verification documentation aligned with the QMS
Support defect investigation, risk assessment, and verification of corrective actions
Test Strategy & Traceability
Contribute to verification strategies, test plans, and impact analyses
Maintain full traceability across requirements, risks, test cases, and results
Participate in readiness reviews (test readiness, release readiness, etc.)
Cross-Functional Collaboration
Collaborate closely with developers, system engineers, testers, and clinical/UX experts
Clearly communicate test progress, risks, and quality assessments to stakeholders
Your Impact Beyond Execution
Drive optimization of verification efforts across the product landscape
Apply risk-based testing strategies, focusing on high-impact areas
Continuously improve verification approaches, balancing manual and automated testing
Act as a cross-team coordinator, aligning verification practices across teams
Promote efficiency, consistency, and sustainability in testing processes
Your Profile
Strong experience in software verification within a regulated environment (medical devices preferred)
Experience with test strategy, traceability, and risk-based testing approaches
Strong analytical mindset and structured way of working
Excellent communication and stakeholder management skills
Ability to work effectively in cross-functional, international teams
Equal Opportunity Employer
As an equal opportunity employer, we welcome applications from individuals with disabilities.
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