Quality Engineer

Confidential Company • Full-time • Cleveland, OH, US • $80k - $100k / year • 5d ago

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.

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