Quality Engineer III
Artech L.L.C. · Maple Grove, MN · 1 mo ago
Quality Assurance$50–$54.58/hrContract
Core Responsibilities
- Support and lead Design History File (DHF) Remediation activities for sustaining medical device products.
- Perform gap assessments, evidence collection, documentation updates, and design control remediation.
- Create/update:
- Design Inputs & Outputs
- Product Specifications
- Component Specifications
- Engineering Drawings/Prints
- Design Review Documentation
- Verification & Validation (V&V) Traceability
Requirements
- Maintain end-to-end traceability between:
- Design Inputs
- Design Outputs
- Risk Controls
- Verification & Validation (V&V)
Must-Have Skills
- 3+ years of Medical Device Industry experience.
- Strong knowledge of Design Controls.
- Experience with:
- Design History Files (DHF)
- Design Inputs/Outputs
- Product Specifications
- Component Specifications
- Engineering Drawings/Prints
- Experience maintaining:
- DFMEA
- Hazard Analysis
- Risk Management Documentation
- Understanding of:
- Verification & Validation (V&V)
- Traceability Matrices
- FDA/ISO Medical Device Design Control Requirements