Senior Quality Engineer Position

Position: Capgemini Senior Quality Engineer Position
Transform product quality in medical device development as a Senior Quality Engineer at Capgemini Engineering in Andover, MA. Own compliance and quality leadership across product life cycles.

Capgemini Engineering is looking for an experienced Senior Quality Engineer to lead quality assurance for regulated medical devices. You will drive compliance with design controls, establish documentation traceability, and manage risk assessments. This role focuses on delivering high-quality standards through effective oversight of both design and software lifecycle activities.

Key Responsibilities:

• Lead quality activities on product development teams

• Ensure compliance with all design control requirements

• Document and maintain complete traceability from user needs

• Manage risk assessment processes and integrate controls

• Support internal and external audits and regulatory documentation

Requirements:

• 10 years of experience in regulated quality engineering

• Extensive knowledge of medical device regulations and standards

• Proven experience in risk management and audits

• Background in software quality management within SDLC

• Exceptional communication skills for team collaboration

Enhance product quality and support compliance at Capgemini Engineering while driving innovation in healthcare technology.
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