Senior Software Quality Assurance Engineer

Karwell Technologies

Andover, MA

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JOB DETAILS

SKILLS

Analysis Skills, Best Practices, Bug Tracking/Defect Management, Change Management, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, External Audit, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Hazard Analysis, IDE (Integrated Development Environment), ISO (International Organization for Standardization), Implants, Internal Audit, International Electro-Technical Commission (IEC), Maintain Compliance, Medical Equipment, Process Improvement, Product Development, Product Lifecycle, Product Lifecycle Management, Quality Assurance, Quality Engineering, Regulations, Regulatory Compliance, Regulatory Submissions, Risk, Risk Management, Root Cause Analysis, Software Administration, Software Design, Software Development Lifecycle (SDLC), Software Testing, Software Validation, Technical/Engineering Design, Traceability, Validation Testing

LOCATION

Andover, MA

POSTED

27 days ago

Job Description:

As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products.
Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post market activities.

Responsibilities:

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).

Requirements:

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.

About the Company

Karwell Technologies

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