Location
Greenville
Job Type
Full-time
Posted
July 02, 2026
Job Description
Job Description: Design Controls Engineer (Contract)
About the Role
The Design Controls Engineer will be responsible for ensuring that all activities related to design controls, risk management, verification/validation, and design transfer are compliant with ISO , FDA CFR , and MDSAP requirements. Unlike traditional medical device companies. This role will act as the central owner of design compliance, bridging those functions into our QMS.
What You'll Do
● Establish and own Our company's Design & Development procedures (ISO §, including templates for Design Plans, Design Inputs/Outputs, Reviews, and Design History Files (DHFs) for Hardware and Software
● Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and change control are integrated.
● Develop and maintain DHFs, DMRs, and MDFs for scanner systems, inks, and associated digital design software.
About the Role
The Design Controls Engineer will be responsible for ensuring that all activities related to design controls, risk management, verification/validation, and design transfer are compliant with ISO , FDA CFR , and MDSAP requirements. Unlike traditional medical device companies. This role will act as the central owner of design compliance, bridging those functions into our QMS.
What You'll Do
● Establish and own Our company's Design & Development procedures (ISO §, including templates for Design Plans, Design Inputs/Outputs, Reviews, and Design History Files (DHFs) for Hardware and Software
● Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and change control are integrated.
● Develop and maintain DHFs, DMRs, and MDFs for scanner systems, inks, and associated digital design software.
Ready to Apply?
Submit your application for Quality/Design Controls Engineer - Remote at INSPYR Solutions
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