Quality Engineer (medical devices)

Job Title - Quality Engineer II

Location: 1441 McGaw Ave, Irvine, CA 92614

Duration: 6 Months Contract

Pay: $46.85/hr

Job Summary:

The Quality Engineer II will apply quality engineering principles to ensure compliance with regulatory requirements and optimize product design, manufacturing, and device distribution. They will also coordinate complaint investigations and support DMR/DHR changes for clinical inventory.

Responsibilities:

• Support Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs
• Investigate product quality and compliance issues, determine root causes, and initiate reviews and reports
• Coordinate and execute change control activities to support innovation
• Support design and development activities, including feasibility testing and drawing reviews
• Participate in escalation tasks and Project Risk Assessments (PRA)
• Lead or support test method development/validation for Design Verification and manufacturing inspections
• Collaborate with R&D and Manufacturing to ensure successful NPD execution
• Develop experiments and tests to improve and validate products and processes
• Maintain technical content of risk management files
• Develop training and documentation materials for seamless knowledge transfer
• Oversee and train technicians on tasks and tests, and provide feedback
• Travel up to 10% domestically and internationally

Required Qualifications:

• Bachelor's degree in Engineering or Scientific field with at least 2 years of experience in NPD, Quality Engineering, R&D, or Manufacturing; OR a Master's degree with relevant internship or project experience
• Engineering experience within a highly regulated industry

Preferred Qualifications:

• Experience in medical devices (cardiovascular, endovascular, or critical care/surgical products)
• Knowledge of Design Assurance, including Design Controls, Verification & Validation, Test Method Development, and Process Validation
• Experience with root cause analysis for Complaints, NCRs, and CAPAs
• Experience with NPD from concept to commercialization (Class III preferred)
• Familiarity with Risk Management and Design Control processes
• Proficiency in MS Office Suite, including MS Project
• Basic understanding of statistical techniques
• Strong problem-solving, organizational, analytical, and critical thinking skills

Additional Information:

• Minimal travel required (up to 10%)
• Experience reading Mandarin documents is a plus, but not required
• Prior complaint handling or CAPA experience is ideal