The Quality Engineer (QE) is responsible for customer-plant liaison, quality cost analysis, specifications, and processes to support manufacturing operations using technical knowledge and software tools as needed.  Responsible for implementing and improving statistical methods, quality cost analysis, specification and procedure development, and conducting internal and supplier quality audits as necessary.  Conduct customer complaint investigations (root cause analysis) and determine the proper actions to be taken.  Lead the efforts for Process Validation as necessary.

• Review customer complaints, analyze returns, and lead implementation of corrective/preventative action(s)
• Review statistical sampling that will ensure adequate quality in our manufactured product
• Monitor all manufacturing processes through audits and daily evaluations, to ensure that processes are being followed and shortcuts are not being taken
• Develop a list of improvement opportunities from quality metrics and systematically develop improvement plans and strategies
• Conduct verification audits of implemented corrective action

Required

• BS Degree in Science / Engineering discipline or equivalent manufacturing experience.
• Experience in product and process failure analysis and understanding quality techniques such as SPC, TQM, etc. 
• Must have demonstrated a record of achievement in problem-solving with production teams
• Must have an understanding of quality techniques for continuous improvement. Six Sigma is a plus
• Understanding of ISO 13485 and FDA 21 CFR 820, 210, and 211 and documentation to support compliance 
• Must understand Statistical Process Control tools

Preferred

• Certified Quality Engineer (CQE)
• CQE and/or CQA
• SSGB or SSBB