Complaints Handler

Job Title : Engineer - Complaints Technical Investigator

Location : Thousand oaks, CA

Duration : 12+ Months

BASIC QUALIFICATIONS

Doctorate degree OR Master’s degree OR Bachelor’s degree OR Associate’s degree

PREFERRED QUALIFICATIONS

Master’s Degree in Science

2+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III

Understand customer / patient use of Client packaged and / or distributed products

Understand manufacturing processes for Client packaged and / or distributed products

Proven experience with medical devices

Demonstrated Six Sigma proficiency specifically for root cause analysis methodology

Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA / FMEA and other Risk Management tools)

Experience with protocol and report writing, process and test development and execution, and design of experiments

Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives

Strong technical writing and interpersonal skills