Process Quality Engineer

6 days ago

Fort Wayne, Indiana, United States Mitsubishi Chemical Advanced Materials Full time
Job Summary

Mitsubishi Chemical Advanced Materials is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest level of quality in our products and processes.

Key Responsibilities
  • Coordinate the preparation and distribution of quality assurance paperwork, including MediTECH and Industrial process and quality assurance documents.
  • Evaluate material qualifications and perform detailed MediTECH and Industrial material certifications.
  • Perform daily in-process audits of MediTECH and Industrial operations, analyzing and reporting potential problems and trends.
  • Perform final audits on MediTECH and Industrial products.
  • Identify, segregate and disposition non-conforming materials.
  • Coordinate and perform inspection and qualification of incoming products and raw material.
  • Coordinate and perform the calibration and maintenance of measuring instruments, process control devices and part gauges, including outsourced calibrations.
  • Assist in the development, implementation and maintenance of a documented quality system that promotes consistency in operations and drives continual improvements.
  • Perform internal and supplier quality system audits as needed.
  • Assist in the investigation, resolution and formal report of customer and internal non-conformances.
  • Maintain document retention and archive system.
  • Coordinating, performing, and leading of Corrective and Preventative Actions.
  • Submit material samples to Lab for testing, and when necessary, perform Quality verification of testing results.
Additional Responsibilities
  • Support Kaiteki plant initiatives.
  • Demonstrate knowledge of Environmental, Health, Safety, and Security (EHS&S) aspects and impacts.
  • Demonstrate knowledge of significant EHS&S aspects and impacts and controls in place.
  • Follow Standard Operating Procedures and JSA's.
  • Understand your role in the EHS&S process and goals.
Requirements
  • Basic working knowledge of physical and mechanical testing.
  • Proficient product inspection and process auditing experience.
  • Skilled in advanced metrology equipment.
  • Proven ability to effectively interpret blue prints and technical specifications.
  • Experience calibrating measurement instruments and operating calibration software.
  • Understanding of the ISO 9001 and ISO 13485 standards, quality system structure and documentation.
  • Familiarity with Quality concepts and tools such as sampling plans, cause-and-effect analysis, root cause analysis, Pareto diagrams.
  • Proficient computer skills in Microsoft Office (Excel, Word, Access) and Movex applications.
  • A proactive and self-motivated work ethic, leadership abilities and a strict attention to detail.
  • Strong oral and written communication skills with the ability to prepare formal reports.
  • Excellent attendance record and proven commitment to the success of the organization.
  • Ability to work effectively both independently and in a team environment.

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