Senior Design Quality Engineer

Role Overview

Capgemini Engineering is seeking a Senior Design Quality Engineer in Andover, MA. The role serves as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases.

• Lead compliance with design controls across planning, input/output, verification, validation, transfer, and change management.
• Establish and maintain DHF, DMR, DHR for full traceability.
• Lead risk management activities (hazard analysis, FMEA, risk files) and integrate risk controls.
• Oversee software SDLC quality, ensuring compliance with IEC 62304 and system-level risk integration.
• Review and approve design, software, and validation deliverables for completeness, consistency, and audit readiness.
• Support verification, validation, and design transfer activities linking design outputs to production processes.
• Lead or support CAPA, nonconformance investigations, and root‑cause analysis to drive continuous improvement.
• Assist internal and external audits (FDA, Notified Body, ISO) and support regulatory submissions (IDE, PMA, EU MDR).

• 10+ years in Quality Engineering supporting regulated medical device development (Class II/III preferred).
• Hands‑on experience with design controls, DHF management, and traceability.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, IEC 62304.
• Experience with software quality in the SDLC and software risk management principles.
• Proficiency in risk management tools (FMEA, hazard analysis) and integration into product development.
• Experience supporting audits and regulatory submissions.
• Strong analytical, documentation, and communication skills; ability to collaborate across cross‑functional teams.
• Familiarity with quality systems, eQMS/PLM tools, and defect/CAPA management.

Base salary: $73,150 – $146,300 (location-based).

• Paid time off, holidays, personal days, sick leave.
• Medical, dental, and vision coverage.
• Retirement savings plans (401(k) U.S.; RRSP Canada).
• Life and disability insurance.
• Employee assistance programs.

Capgemini is an Equal Opportunity Employer encouraging inclusion. All qualified applicants will receive consideration without regard to race, national origin, gender, age, religion, disability, sexual orientation, genetics, veteran status, marital status, or any other protected characteristic. Reasonable accommodations will be provided during the recruitment process.