Quality Engineer

September 13, 2022

Quality Engineer

Cold Chain Technologies Tennessee
September 13, 2022
1080 Richard Petty Way, Lebanon, Tennessee
Job Type



Under the direction of the Sr Quality Manager, TN Site, perform quality engineering duties including, manufacturing support, quality monitoring, problem solving, process improvement, CAPA management and internal/external auditing.


  • Drive the identification, implementation, and use of statistical methods throughout the plant. Statistical methods include Statistical Process Control (SPC), Designed Experimentation (DoE), and acceptance sampling among others.
  • Establish, monitor, analyze, and report on the major quality indicators for the plant. Utilize accepted capability indicators (CP, CpK, PPM, etc.).
  • Create and facilitate problem-solving teams; including the use of problem solving tools such as FMEA.
  • Investigate, analyze, develop and determine processes and process improvements on existing products to improve quality and or productivity.
  • Develop and implement quality tools in the line such as defect tracking, random audits, verification check sheets, etc.
  • Assist Sr. Quality Manager in establishing, implementing and maintaining the quality management system.
  • Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
  • Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
  • Analyze failure, corrective and preventive action to respond to customer complaints.
  • Interface with external customers on quality-related issues.
  • Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
  • Perform duties in accordance with established quality standards.
  • Actively support Health, Safety and Environment rules and regulations.


  • BS in Manufacturing or Industrial Engineering or other technical field with 2 – 4 years of experience or Associates degree in technical field with 5-7 years of experience
  • Experience in MRB, design reviews, corrective action programs.
  • Basic understanding of QA standards, implementation and auditing.
  • Basic understanding of statistical techniques and analyses.
  • Knowledge and use of MS Office applications, integrated MRP database applications, and experience with Minitab also desired.
  • Excellent verbal and written communication skills.
  • Experience in driving improvement initiatives.
  • Ability to integrate and work well in a team environment.
  • Ambitious self-starter with drive to implement and achieve desired results.
  • Effectively manage multiple and changing priorities.
  • Ability to work in a very fast-paced environment.
  • Ability to lift 50 lbs. on occasion.
  • Occasional travel required.


  • Working knowledge of ISO 9001:2015
  • Knowledge and experience with ISO 13485
  • ASQ Certified Quality Engineer or Certified Quality Auditor.
  • Six sigma green / black belt certified and Lean Manufacturing experience.
  • Experience in a cGMP and FDA regulated environment preferred.
  • Quality systems auditing experience; preferably as a lead auditor.
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