Junior Quality Engineer (Medical Devices)

Location: San Clemente, California 92673, United States

Salary: $66,600–$77,000 per year

Company

hirify.global is partnering with a medical device organization on a quality engineering assignment.

What you will do

• Support consumable product development and Design History File remediation.
• Apply risk management, validation, design verification, and root-cause investigation tools.
• Drive conformance with FDA regulations, ISO 13485, ISO 14971, EU MDR, and other applicable standards.
• Participate in design reviews, risk assessments, cross-functional project teams, and design transfers.
• Evaluate and mitigate product and process risks to support continuous quality improvement.
• Support audits, inspections, and on-market product investigations through resolution.

Requirements

• Bachelor’s degree in electrical, mechanical, biomedical engineering, or a related technical discipline.
• 0–2 years of professional experience in R&D and/or quality engineering.
• Familiarity with Design History File remediation, quality engineering principles, and EU MDR 2017/745.
• Strong communication skills and the ability to collaborate across engineering and operations teams.
• Must be at least 18 years old.

Culture & Benefits

• Professional office environment with standard equipment.
• Primarily sedentary role with less than 5% travel.
• For temporary assignments lasting 13 weeks or longer: medical, dental, vision, 401(k), and statutory sick pay where required.
• Reasonable accommodations are available for individuals with disabilities.