Quality Engineer

June 20, 2022

Quality Engineer

Cold Chain Technologies Tennessee
Published
June 20, 2022
Location
1080 Richard Petty Way, Lebanon, Tennessee
Category
Quality  
Job Type

Description

JOB DESCRIPTION:

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.

RESPONSIBILITIES:

  • 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.

QUALIFICATIONS :

  • 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.

PREFERRED QUALIFICATIONS:

  • 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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