Pacer Staffing LLC

Quality Engineer

Job Title: Quality Engineer

Duration: 06 Months

Location: Irvine CA

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 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
  • Seniority level

    Entry level
  • Employment type

    Full-time
  • Job function

    Quality Assurance
  • Industries

    Medical Equipment Manufacturing

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