Quality Engineer to support the remediation of products relative to the European Medical Device Regulations (MDR), ensuring products maintain quality standards, comply with regulatory and compliance standards.
Will update Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) to ensure MDR legislation compliance. Will update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation. Will provide R&D engineering support for Quality and MDR compliance activities including correcting quality problems, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records.
- Bachelor’s degree in Mechanical Engineering, Biomechanical Engineering, or other related engineering field.
- U.S. Citizen or Green Card Holder.