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# Design Quality Engineer

- **Company:** The Atlantic Group Inc
- **Location:** Waltham, MA, United States
- **Experience:** Expert
- **Salary:** $104,000.0 - $135,200.0
- **Contract:** Temporary contract
- **Skills:** Document Management Systems, Software Engineering, Verification and Validation (Software), Information Technology
- **Published:** September 16, 2026
- **Apply:** https://atlanticrecruiters.com/jobs/design-quality-engineer/

## About the Role

Atlantic Group is hiring multiple Design Quality Engineers in Waltham, MA for our client, supporting a critical quality remediation initiative within a regulated medical device environment. This role will focus on Design History File (DHF) remediation, software design controls, documentation traceability, quality system compliance, and regulatory inspection readiness. The ideal candidate has 5+ years of quality engineering or design assurance experience with strong knowledge of medical device design controls and software-related quality documentation., * Education: Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Life Sciences, or a related technical field is required.

 * Experience: 5+ years of quality engineering, design assurance, design controls, or related regulated product experience is required.
 * Industry Knowledge: Medical device or related regulated product experience is required, with strong knowledge of Design History Files, design controls, verification and validation, and risk management.
 * Regulatory Knowledge: Knowledge of FDA medical device quality requirements and ISO 13485 is required.
 * Technical Skills: Experience with quality documentation, audits, design control processes, and electronic quality management systems is required.
 * Skills & Attributes: Strong analytical, documentation, organizational, communication, problem-solving, attention to detail, and cross-functional collaboration skills are required.

## Description

* Design Quality: Review design documentation and quality records to identify gaps and support compliance with established design control requirements.
 * Design Controls: Support Design History Files, design documentation, verification and validation, and related quality engineering activities.
 * Quality Documentation: Review requirements, risk documentation, testing records, and supporting quality documentation for accuracy and traceability.
 * Regulatory Compliance: Support audit and inspection readiness while addressing quality and documentation issues.
 * Document Control: Maintain accurate design and quality records within electronic quality systems while supporting document control activities.
 * Cross-Functional Collaboration: Partner with engineering, quality, regulatory, and other technical teams to resolve quality issues and improve design control processes.