Quality Engineer

Greenville, NC, US
Posted 6 days ago by FPC Savannah

Job Description

The Quality Engineer will work closely with operations and engineering to reduce scrap and drive continuous improvement activities to reduce customer complaints and lower the response time. This position will investigate internal and external quality issues and identify root cause, using data analysis, data trending and periodic reporting. This position reports to the Quality Manager.

Essential Job Duties and Responsibilities

  • Ensure product and process validations are completed.
  • Perform discrepant material disposition with guidance.
  • Recommend inspection plans, test methods, and standard operating procedures.
  • Conduct sample size determination, statistical analysis, root cause analysis and applicable training.
  • Maintain process failure modes and effects analysis (FMEA) documentation.
  • Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives.
  • Collect and trend quality indicators for monthly and quarterly reviews.
  • Individually contribute to problem solving teams using common investigation processes/tools.
  • Perform routine engineering assignments which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, and theories.
  • Support documentation development including writing specifications for manufacturing or scientific test results.
  • Support management, implementation & documentation of IQ, OP, PQ.
  • Participate in continuous improvement projects.
  • Assist in Internal Audit process and in addressing observations.

Position Skills and Experience Requirements

  • Bachelor’s degree in Engineering field. Must have 4-year degree.
  • 1 - 2 years related experience in Medical Device manufacturing.
  • Ability to independently complete problem-solving tasks.
  • LEAN/6 sigma experience a plus.
  • Demonstrated knowledge and understanding of Statistical Process Controls
  • Basic understanding of engineering and mathematics principles.
  • Understand interpretation of drawings, specifications, blueprints, and etc.
  • Able to use inspection and measuring instruments such as calipers, micrometers, tensile strength testers (e.g. Instron or Chatallion), etc.
  • Highly motivated, detail-oriented, eager to learn.
  • Strong analytical, problem solving and teamwork skills are required.
  • Able to follow instructions in all formats: written, verbal, and electronic.
  • Excellent time management, prioritization abilities, and strong project management skills
  • Ability to develop and implement strategies
  • Strong analytical skills, with 80/20 mindset
  • Ability to work with and manage complexity/change
  • Demonstrated ability to make tough decisions
  • Excellent interpersonal, communication, and presentation skills
  • Ability to generate respect and trust from staff and external constituencies along with the ability to work collaboratively with colleagues and staff to create a results driven, team-oriented environment
  • Personally driven and motivates others to excel
  • Ability to use MS Office Tools such as Word, Excel, Project, and MiniTab®.


Recruiters Details

Greenville, NC, US
Job number:
David Varon
Posted At:
6 days ago
Job Function:
Quality Engineer
Medical Devices & Diagnostics