Design Quality Engineer (Medical Devices)

Location: San Clemente, CA 92673; professional office setting

Salary: $32–$36 per hour

Company

hirify.global provides staffing and temp-to-hire engineering opportunities, including work supporting regulated medical device products.

What you will do

• Support quality engineering activities for medical device consumable development and Design History File remediation.
• Apply risk analysis, validation, design verification, CAPA data, investigations, and product/process controls.
• Participate in design reviews, test readiness reviews, risk assessments, design transfers, and cross-functional project meetings.
• Help verify that design changes meet quality requirements and applicable regulations and standards.
• Support investigations, CAPA activities, on-market product quality issues, audits, inspections, and special projects.

Requirements

• Early-career engineering experience or professional background suitable for hands-on work in a regulated environment.
• Ability to support medical device quality engineering and design quality activities.
• Understanding of quality tools, risk assessments, validation, design verification, investigations, and product/process controls.
• Ability to collaborate with engineering, quality, regulatory, and product teams.
• Willingness to work in a largely sedentary office role and travel typically less than 5%.

Culture & Benefits

• Temp-to-hire employment arrangement.
• Professional office environment with collaborative teamwork and supportive leadership.
• Opportunity to contribute to product quality and patient safety in a highly regulated industry.
• For temporary assignments lasting 13 weeks or longer: major medical, dental, vision, 401(k), and statutory sick pay where required.