What are the responsibilities and job description for the Design Quality Engineer position at United Consulting Hub?
Job Title: Senior Design Engineer / Design Quality Engineer (Medical Devices)
π Location: US
πΌ Work Type: W2
π Experience: 6 Years (US Experience Required)
Job Description:
Seeking an engineer with strong medical device background to support design, quality, and compliance activities. Role involves leading design controls, V&V, documentation, and cross-functional collaboration.
Key Responsibilities:
- Support/lead medical device design & development
- Manage Design Controls, DHF, Risk Management (ISO 14971)
- Perform V&V testing and documentation
- Ensure compliance with FDA 21 CFR 820 and ISO 13485
- Review drawings/specs and support investigations/CAPA
Required Skills:
- 6 years US medical device experience
- Strong knowledge of design controls, V&V, QMS
- Experience with risk assessments, FMEA, testing
- Collaboration with R&D, Quality, Regulatory teams
π© Apply β Interviews ASAP! πΌπ
navya@unitedconsultinghub.com
π 1 (551) 300-0477 Ext. 108