Product Quality Engineer

1 month ago

Irvine, United States Pacer Staffing Full time

Job Title: Product Quality Engineer

Location:

Irvine, CA

Duration: 06+ Months

Job Description

Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions. Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner. Oversight of all complaints that require investigation through the different phases. Ensure on time completion of complaints. Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed. Ensure complaint investigations are adequate and comply with applicable procedures. Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and procedures to optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities

Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Other incidental duties assigned by Leadership

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