Our client, a medical device manufacturing company, has an immediate opening for a Quality Inspector. The Quality Inspector is responsible for performing daily inspections, including assessment of non-conforming product, process issues and need for corrective / preventive action, and communicating findings to the Quality and the area manager.

Responsibilities:

• Use specialized inspection/test equipment to qualify/verify product. Qualification/verification of product includes the ability to properly set up parts on equipment to be measured, run established measurement programs, and identify pass/fail results from reports generated. Inspection/Test equipment includes, but is not limited to:
  • Coordinate Measuring Machine (CMM)
  • Vision Systems such as
    • Keyence Optical Measurement Systems
    • Micro Vu Video Measuring Machine
  • Optical Comparator (standard and eCAD)
  • Micrometer
  • Calipers
  • Drop indicator
  • Pull-force tester
  • Hardness tester
• Complete Quality records accurately and legibly, file appropriately
• Coordinate MRB activities including but not limited to:
  • Identifying and immediately segregating nonconforming material
  • Appropriately tagging nonconforming material
  • Logging nonconforming material information
  • Consulting on disposition
• Evaluate nonconforming material to provide input regarding condition
• Identify opportunities for corrective/preventive action
• Perform follow-up/effectiveness checks with guidance from Quality Engineers
• Complete all final product release activities
• Perform data entry to support monitoring of quality/performance trends
• Perform documentation review and dimension verification on received materials
• Complete First Article Inspection using documentation/guidance provided by Quality Engineering
• Perform in house calibrations of gages following work instructions
• Provide measurement and documentation support to validation activities
• Verify product visually and dimensionally through in-process inspections

Requirements:

• High School Diploma or GED
• Ability to read and comprehend written work instructions
• Ability to understand verbal instructions
• Basic computer skills to input daily information
• Competent with Microsoft Office Program
• Familiar with ISO 13485 standard and CFR 820 regulations
• General understanding of Statistical Process Control principles
• Ability to read and interpret prints and customer requirements
• Proficient with standard dimensional gages-caliper, micrometer, drop indicator, comparator
• Ability to set-up, run programs and identify pass-fail results on more sophisticated inspection/test equipment such as (but not limited to) vision systems, CMM’s, and optical comparators