Design Quality Engineer

Job Summary

Seeking a skilled Design Quality Engineer, the full-time contract position will support product development and quality engineering for innovative medical devices, focusing on Design Controls, Risk Management, and compliance with FDA/ISO 13485 regulations.

Key responsibilities:

• Support Design Quality activities throughout the product development lifecycle
• Ensure compliance with FDA Quality System Regulations and ISO 13485 requirements
• Perform Design Verification and Design Validation (DV&V) activities

Required qualifications:

• Bachelor's degree in Mechanical, Biomedical, Electrical, Industrial, Chemical Engineering, or related discipline
• 3+ years of Design Quality Engineering experience in the Medical Device industry
• Strong knowledge of Design Controls and medical device product development
• Experience with Risk Management (ISO 14971, DFMEA, PFMEA)
• Knowledge of FDA 21 CFR Part 820/QMSR and ISO 13485