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# Senior Software Quality Assurance Engineer

- **Company:** Ztek Consulting
- **Location:** Andover, MA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Software Quality, Failure Mode Effects Analysis, Systems Development Life Cycle, Verification and Validation (Software), Software Quality Assurance (SQA)
- **Published:** July 3, 2026
- **Apply:** https://www.careerjet.com/jobad/us8ce2f575a743cc593272602ec0db1d82

## About the Role

* Bachelor's degree in engineering (Biomedical, Software, Systems) or a related technical discipline
 * Advanced degree (Master's) in Engineering, Quality, or Regulatory Affairs preferred
 * Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus, * 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
 * Strong hands on experience with design controls, DHF management, and traceability in regulated environments
 * Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
 * Experience supporting software quality within the SDLC and understanding of software risk management principles
 * Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
 * Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
 * Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
 * Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes, Job Description: Working from client office: Yes (Hybrid 3 days per week). Qualifications: Bachelor's degree in Engineering (Biomedical, Software, Systems) or a related technic…
 + 5 days ago

## Description

In this role you will play a key role in:

 * Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
 * Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
 * Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
 * Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
 * Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
 * Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
 * Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
 * Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)


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