Design Quality Engineer

Title: Design Quality Engineer I

Location: 951 Calle Amanecer, San Clemente, CA 92673 United States

Pay rate: $32 to $37/hr on W2.

Key Responsibilities:

• Support consumable product development and Design History File (DHF) remediation activities.
• Assist with CAPA investigations, risk assessments, design reviews, verification, validation, and design transfer.
• Ensure compliance with FDA regulations, ISO 13485, ISO 14971, EU MDR 2017/745, and quality system requirements.
• Support audits, inspections, and continuous quality improvement initiatives.
• Collaborate with cross-functional teams to identify, assess, and mitigate product and process risks.

Qualifications:

• Bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, or related field).
• 0–2 years of experience in Quality, R&D, Product Design, or Product Engineering.
• Knowledge of DHF Remediation and EU MDR 2017/745 preferred.
• Strong communication and problem-solving skills.

Work Environment:

• Office-based, primarily sedentary role.
• Less than 5% travel required.