Design Quality Engineer - Intellectt INC

Title: Design Quality Engineer
Location: Middletown, VA (Onsite)
Duration: 6+ Months

Note: IVDR experience is required.

Key Responsibilities:

• Apply and implement IVDR 2017/746 and ISO 13485 standards.
• Manage DHF creation, maintenance, and design control processes.
• Develop and maintain records and procedures within the Quality Management System (QMS) to ensure regulatory compliance.
• Support regulatory audits and certification inspections to maintain operational compliance.
• Assess and interpret regulatory requirements and industry standards relevant to business operations.