Design Quality Engineer

Job Description

Job Description

Summary:
Our client is a large medical device manufacturer currently undergoing a large-scale acquisition and integration initiative. They are currently seeking a Senior Design Quality Engineer to support design quality integration, remediation, and harmonization activities across acquired businesses and legacy quality systems. This individual will serve as a technical leader partnering closely with Engineering, Regulatory, Manufacturing, and Program Management teams to ensure compliant integration of design control processes and product development activities within the unified Quality Management System.

• This individual will be responsible for leading high-level Design Quality Engineering activities across complex medical device programs while ensuring compliance with FDA, ISO 13485, and global regulatory requirements.
• This person will work cross-functionally to develop and improve design control processes, risk management activities, and verification and validation strategies for both hardware and software-based products.
• Additional responsibilities include overseeing design reviews, risk assessments, traceability activities, and product development deliverables throughout the design lifecycle.
• This individual will provide technical leadership for quality and compliance initiatives tied to product development, remediation, sustaining engineering, and process improvement projects.
• They will also support integration of quality system requirements into engineering and product development workflows while helping mentor junior engineers and influence best practices across the organization.

• Design Controls
• Mechanical/Electrical Engineering Background
• Risk Management
• DHF Remediation / Design Remediation
• Verification & Validation (V&V)
• Change Controls
• Root Cause Analysis / CAPA support
• Process Improvement.
• Working knowledge of electronic assemblies
• Acquisition or integration project experience