Quality Engineer

Quality Mt Pleasant, Tennessee


Description

The position will be responsible for process capability studies and understand the products, processes, and quality controls at the GCP sites manufacturing SBM. QC data, product quality complaints and product quality warranty repair data will be reviewed for trends and recommended countermeasures.

  • Administer and promote root cause analysis for top quality issues identified by the business. Use tools like fishbone diagram, 5 why, is/is not, fault tree analysis, pareto analysis, and DOE to determine the root cause then confirm corrective actions via testing.
  • Analyze data from trials including DOEs to ensure product and processes are maintained or improved by any changes.
  • Develop plans and lead trials for 3M changes (raw material, method, or machine) via the CQV process. Ensure these changes don’t result in process that aren’t capable.
  • Participate in New Product Process including development of DFMEA and CQV of new product production.
  • Develop and maintain process flow chart, PFMEA, and control plan for all production processes.
  • Lead project teams to ensure all production processes are in control. Establish control charts for process characteristics demean critical for product performance.
  • Perform MSA to ensure plant measures are capable including work with our R&D Laboratory. Ensure plant product quality testing meets ASTM or other regulatory requirements.

 Responsibilities:

  • The purpose of the job is to reduce risk and assure product and process conformity.
  • Teammate will use Quality tools to perform their job function.
  • Teammate will be developing and implementing new standards associated with 3M (management of change) and Commission, Qualify & Validate (IQ, OQ, PQ) new and existing product lines. Provide testing plans and analyze data to make recommendations on approval or rejection.
  • Teammate will provide guidance and direction associated with analyzing and reducing risk associated with product launches and new production lines.
  • Teammate will be working with Marketing, Procurement, R&D, Sales, Process Engineering, Operations, and Technical Services as well as suppliers and customers.
  • Responsible for instructing, directing, developing standards for trials that reduce risk and assure we are providing product conforming to our internal specifications.
  • Responsible for providing reliable input as necessary and knowledge of industry standards. Quality testing and requirements.

 

Qualifications:

  • Bachelor in Math or Engineering preferred. ASQ certifications preferred.
  • Use of problem-solving, process mapping, PFMEA, control plans, measurement system analysis and SPC required. Experience creating and analyzing data from a DOE also required.
  • A minimum of 5 years applied experience quality functions.
  • Knowledge of ISO 9000, auditing and quality tools is preferred.
  • Six Sigma certification and training in lean principles is ideal.