Senior Design Quality Engineer

Our client is seeking a dedicated and experienced Senior Design Quality Engineer to join their dynamic team. As a Senior Design Quality Engineer, you will be part of the Quality Assurance department supporting cross‑functional teams. The ideal candidate will demonstrate strong analytical skills, effective communication, and a proactive approach to quality management, which will align successfully in the organization.

Job Title: Senior Design Quality Engineer

Location: Andover, Massachusetts

Contract on W2

• Serve 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)
• Establish and maintain Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR), ensuring complete traceability from user needs through verification and validation evidence
• Lead and maintain risk management activities, including hazard analysis, FMEA, and risk files, integrating risk controls into design and validation activities
• Provide quality oversight of software Software Development Life Cycle (SDLC) activities, ensuring compliance with standards such as IEC 62304 and integrating with system‑level risk management
• Support verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes

• 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

• Collaborate with a talented and diverse team of professionals
• Engage in meaningful projects that foster professional growth and development
• Work in a supportive environment that values quality and compliance
• Be part of a forward‑thinking organization committed to excellence

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay