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Quality Engineer

2 months ago

Irvine, United States Infosoft, Inc. Full time

Job Title: Quality Complaints Engineer (Complaint Investigations)

Pay Rate: $40 to $44.61/HR

Duration: 6 months

Location: Irvine, CA (Onsite)

Our Client is a Global medical device Manufacturer.

We are looking for a Quality Complaints Engineer (Complaint Investigations).

  • 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 clients' systems/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.
  • 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


Education/Experience:

  • Bachelor's degree in engineering required.
  • 1-2 years experience required.