Quality Engineer Job

Responsibilities

 Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer.
 Perform quality audits and/or inspections.
 Develop and implement statistically valid sampling plans, design of experiments, capability studies, SPC and trend analysis.
 Lead and/or participate in process and product corrective actions and problem-solving activities.
 Constantly review the current quality system and recommend / implement improvements as needed.
 Review collected data to perform statistical analysis.
 Participate on projects focused on quality system, product quality and service quality improvement.
 Collect data and prepare reports on the trends of the quality system key performance metrics.
 Participate/support external and internal quality system audits.

Requirements

 Bachelor's Degree in Engineering or related technical field required.
 1+ years of combined Quality, Process, Manufacturing, Project, Design, Development and/or Test Engineering experience with the desire to focus on Quality Engineering as a career interest.
 Experience and understanding of working with various Quality Management Systems.
 Experience in a manufacturing setting; preferably in a regulated environment…Medical Device would be ideal.
 Experience working in an ISO certified environment is required; ISO 13485:2016 is preferred.
 Experience with EO sterilization validation is a plus.
 Experience with root cause analysis tools.
 Experience working on cross-functional teams and on own initiative.