Quality Engineer III

Maple Grove, Minnesota
Full Time

Email Address

Apply Now

Design Quality Engineer III
Job ID: 19152-1
Location: Maple Grove, MN 55311 Onsite
Duration: 12+ Months
Payrate: $50.00 - $54.58/HR. on W2 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
Maintain end-to-end traceability between:
- Design Inputs
- Design Outputs
- Risk Controls
- Verification
- Validation
Lead updates to DFMEA and Hazard Analysis documentation.
Support audit/inspection readiness and regulatory compliance.
Collaborate with R&D, Manufacturing, Regulatory Affairs (RA), Document Control, and Quality teams.

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