QA Design Engineer - Medical Devices

Hello

Hope you are doing well.

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at 1(732)-276-1791

Job Title: QA Design Engineer

Location: Virginia, USA

Job Description

• Apply knowledge of IVDR 2017/746 and ISO 13485 to ensure regulatory compliance.
• Create and maintain Design History Files (DHF) and manage design control processes.
• Develop and update records and procedures within the Quality Management System (QMS) for regulatory adherence.
• Assist in regulatory audits and inspections to ensure compliance with established procedures.
• Interpret regulatory requirements and industry standards applicable to operations.
• Conduct thorough compliance assessments to identify gaps and recommend improvements.
• Implement compliance strategies and action plans to address identified gaps.
• Monitor and oversee compliance initiatives and projects.
• Lead and participate in compliance and quality training programs.
• Support internal audits to maintain operational compliance with regulatory requirements.
• Continuously improve the Quality Management System in line with evolving regulatory standards and best practices.
• Provide reports, analysis, and feedback on QMS performance, leading indicators, and KPIs related to compliance.