complaint investgation

Role: Engr I

Location: Irvine, CA - 92614

Duration: 06 Months on W2

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 Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.

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