Design quality engineer

Job Title: Junior Design Quality Engineer

Location: Texas

Employment Type: Contract (W2 Only)

Job Summary

We are seeking a motivated Junior Design Quality Engineer to support design quality, risk management, and product development activities within a regulated medical device environment.

The ideal candidate will assist with design controls, risk assessments, design verification documentation, and quality system activities while collaborating with cross-functional engineering teams.

Key Responsibilities

• Support design quality and design control activities throughout the product lifecycle
• Assist in preparing and maintaining Risk Management Files in accordance with ISO 14971
• Support Design Verification and Validation (V&V) documentation
• Participate in design reviews, CAPA, and change control activities
• Assist with Design History File (DHF) documentation and engineering records
• Collaborate with R&D, Manufacturing, Regulatory, and Quality teams
• Support risk assessments, FMEA activities, and continuous improvement projects
• Ensure compliance with FDA, ISO 13485, and company quality standards

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Chemical Engineering, Life Sciences, or related field
• 0–2 years of experience in Design Quality, Quality Engineering, or medical device product development
• Basic understanding of:
• Design Controls
• ISO 14971
• ISO 13485
• FDA Quality System Regulations (QSR)
• Risk Management and FMEA
• Strong analytical, documentation, and communication skills
• Proficiency in Microsoft Office