Design Quality Engineer

• 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.

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.