Looking to bring on a Quality Engineer Level II candidate into our growing organization. We are looking for someone with a Electro-Mechanical Medical Device background but open to other engineering degrees.
- Design Input creation - Reviewing specified requirements
- Design Output Creation and Review: Drawings, Engineering Specification review, Input for Design for Manufacturability/Design for Inspection, Receiving inspection documents
- Associated product Reviews
- Risk Management Plan
- Design Verification/Validation
- Review of Surgical Technique, Labels, and IFUs
- Design History File Phase Gate Deliverable per Design Control Procedure
- Quality Assurance: ensuring compliance of all the project deliverable to procedures governing the new product development process
- Process Validation/Process Verification
- 3+ years of Medical Device experience
- Design Validation and Verification
- Understanding of design controls
- Must be able to work in the US without sponsorship
Sthree US is acting as an Employment Business in relation to this vacancy.