Website TRIAD Engineering Corp
Our client, a leader in the medical device industry, is seeking a Quality Engineer to join their growing team to improve the overall process and outputs for their operation. The Quality Engineer will develop and implement quality standards and systems as well as perform IQ, OQ and PQ on equipment and processes. The selected candidate will also work to identify process problems, implement corrective actions, solutions and improvements as well as work with managers to determine customer risk management activities (PPAP programs, etc.). In addition the Quality Engineer should have experience with ECO and CAPA generation and assisting with MRB dispositions and will ensure that workflows, processes and products comply with safety regulations.
• Bachelor of Science in Engineering desired.
• Minimum of 10 years’ experience in a manufacturing/quality role required.
• Medical device manufacturing experience desired, other regulated environments may be considered.
• Monitor and analyze quality performance and have broad background with the use of QA software tools and processes.
• Lean manufacturing and Kaizen skills are a plus
• CMM experience helpful (Zeiss tools and Calypso software ideal)
• Calibration maintenance experience beneficial.