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.
