Quality Engineer III
Job in
Osseo, Hennepin County, Minnesota, 55369, USA
Listed on 2026-06-04
Listing for:
Artech LLC
Full Time
position Listed on 2026-06-04
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
Design Quality Engineer III
Job
-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.
- 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
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×