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 lifecycles.
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
• Ex...