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# Quality Systems / Design Assurance Engineer

- **Company:** DEV X, LLC
- **Location:** Irvine, CA, United States
- **Experience:** Experienced
- **Salary:** $81,490.0 - $98,138.0
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Requirements Management
- **Published:** July 4, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=c82dbfa9ea34defb

## About the Role

We are seeking a Quality Systems / Design Assurance Engineer to support medical device quality systems and product development activities in compliance with U.S. FDA regulations. The ideal candidate will have hands-on experience with design controls, quality management systems, and medical device risk management throughout the product development lifecycle., * Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.

 * Experience working within a medical device Quality Management System (QMS) aligned with U.S. FDA regulations.
 * Hands-on experience with design requirements, design controls, and risk management processes.
 * Strong understanding of:

 * Complaint trending and analysis

 * Hazard identification and hazard analysis

 * Risk documentation and risk assessments
 * Excellent analytical, documentation, and problem-solving skills.
 * Strong verbal and written communication skills with the ability to work effectively on cross-functional teams.

Preferred Qualifications

 * Experience with medical device product development.
 * Knowledge of FDA Design Controls and Quality System Regulation (21 CFR Part 820/QMSR).
 * Experience applying ISO 14971 risk management principles.
 * Experience preparing or maintaining dFMEA, Risk Management Plans (RMP), and Risk Management Reports (RMR).

Preferred Skills

 * Medical Device Quality Management Systems (QMS)
 * FDA Regulations (21 CFR Part 820/QMSR)
 * Design Controls
 * Requirements Management
 * Risk Management
 * ISO 14971
 * dFMEA
 * Hazard Analysis
 * Complaint Handling and Trending
 * System Risk Assessments
 * Technical Documentation
 * Cross-functional Collaboration

Pay: $81,489.98 - $98,138.48 per year

Education:

 * Bachelor's (Required)

Experience:

 * medical device Quality Management System (QMS) : 3 years (Required)

## Description

* Support and maintain medical quality systems in alignment with U.S. FDA expectations and applicable regulatory requirements.
 * Develop, review, and manage design requirements, including:

 * User Needs

 * Stakeholder Needs

 * Product Requirements
 * Support design control activities throughout the product development process.
 * Perform risk management activities in accordance with industry standards, including:

 * Historical complaint analysis and trending

 * Identification of hazards and hazardous situations

 * Design Failure Mode and Effects Analysis (dFMEA)

 * System-level risk assessments

 * Development and maintenance of Risk Management Plans (RMP)

 * Preparation and maintenance of Risk Management Reports (RMR)
 * Collaborate with cross-functional teams to ensure design documentation is complete, accurate, and compliant with regulatory requirements.
 * Support continuous improvement initiatives within the Quality Management System (QMS).


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