Senior Design Quality Engineer

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life‑saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities.

Where you can make a difference. Where no two days are the same.

Location:

Andover, MA – Onsite (4 days/week)

Capgemini Engineering are actively looking for Senior Design Quality Engineer with senior QA who will be 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).

• 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)

• 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

The base compensation range for this role in the posted location is: 73,.

Capgemini offers a comprehensive, non‑negotiable benefits package to all regular, full‑time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:

• Paid time off based on employee grade (A‑F), defined by policy:
  Vacation: 12‑25 days, depending on grade, company paid holidays, personal days, sick leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.