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# Design Quality Engineer

- **Company:** Spectraforce
- **Location:** Warsaw, IN, United States
- **Contract:** Temporary contract
- **Skills:** Microsoft Excel, Data Analysis
- **Published:** November 12, 2026
- **Apply:** http://leoforce.us/Careers/Spectraforce/JobDetails.html?jobid=c5f04866-3e66-4ae3-8694-dcf7d7e7a937&OrgId=1&UserId=2445

## About the Role

* Working knowledge of ISO 13485, 21 CFR 820, and EU MDR.
 * Experience with Design Controls and risk management, particularly as related to electronic device design.
 * Statistical knowledge, including understanding of measurement uncertainty, and experience with statistical analysis and techniques.
 * Detail-oriented and well organized, with excellent communication skills.
 * Able to accomplish objectives with general supervision and escalate issues appropriately.
 * Apply scientific principles and problem-solving, scientific rationale, and technical logic to engineering activities and development decisions.
 * Evaluate, implement, and validate design changes to existing products; collaborate with Engineering, Legal, Manufacturing, Operations, and Operations Transfer teams to support development workflows and product/process transfers into manufacturing and supplier environments.
 * Advanced Excel skills, including data analysis and reporting; advanced English communication skills, both written and verbal.

## Description

Position Summary: The Design Quality Engineer supports robust and compliant design control practices for sustaining engineering activities. The role serves as a quality representative on cross-functional teams, supporting compliance with regulatory requirements such as 21 CFR 820, ISO 13485, and EU MDR, as well as internal quality standards.

Background & Context: It also collaborates with Legal, Manufacturing, Operations, and Operations Transfer partners to support compliant development and product/process transitions. The Design Quality Engineer supports design changes, risk management activities, quality documentation, complaint investigations, and continuous improvement throughout the product lifecycle., * 20% Support design verification and validation, risk management, and design reviews to help ensure product safety, performance, and regulatory requirements are met.

 * 20% Review engineering design changes and provide quality input on documentation, traceability, and risk assessment; support continuous improvement of design processes, templates, and procedures.
 * 40% Provide quality support for sustaining engineering projects, product improvements, and Operations Transfer activities, including transfer of products and processes into manufacturing and supplier environments.
 * 20% Assist with quality deliverables for regulatory submissions, including 510(k), technical documentation, and IDE-related documentation; support audits, quality metrics, management review inputs, and other quality-related duties assigned by management.