Quality Engineer – Customer Complaints & CAPA (Medical Devices)

Tasks

• Customer complaint investigations
• Root cause analysis
• Corrective and preventive actions (CAPA)

Requirements

• Bachelor's degree in Engineering.
• Minimum of 2 years of experience in an engineering-related field.
• Ability to read and interpret electrical and mechanical schematics.
• Experience or understanding of root cause analysis, complaint investigations, and problem-solving.
• Knowledge of statistical analysis and continuous improvement methodologies.
• Strong analytical, organizational, written, and verbal communication skills.
• Ability to prioritize multiple tasks and collaborate effectively with cross-functional teams.
• Preferred: Experience in the medical device industry, particularly with capital equipment.
• Preferred: Knowledge of CAPA, NCR, and audit management systems.
• Preferred: Familiarity with ISO 13485, FDA Quality System Regulation, and ISO 14971.
• Preferred: Understanding of FMEA, Fault Tree Analysis, risk management, and design controls.
• Preferred: Exposure to Six Sigma, process excellence, Minitab, or QI Macros.

Schedule

• 5-Month Contract (Potential Extension)
• Monday–Friday
• Onsite

How to apply

• Please apply on the below Job Posting or share your resume directly with me on email.

Location

• Irvine, CA 92618