CE
Senior Design Quality Engineer
Accepting applicationsCapgemini Engineering · Andover, MA
Full-Time Mid_senior aiate
Posted
2d ago
Category
Verification
Experience
Mid_senior
Country
United States
Location : Andover, MA - Onsite (4 days/week)
About the job you’re considering
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)
Your role
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)
Your skills and experience
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
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About the job you’re considering
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)
Your role
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)
Your skills and experience
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
Show more Show less