Automated Quality Inspector

Summary

The Automated Quality Control Inspector operates CMM equipment to perform measurement, inspector, and testing of production materials and components using prepared inspection programs.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Operate CMM equipment to inspect parts per engineering specifications.
• Determine quality (pass/fail) of manufactured parts based on dimensional and visual inspection
• Read and interpret blueprints and specifications.
• Conduct visual and mechanical inspections of machined components in accordance with published inspection instructions:
  • First article inspection
  • In-process visual and deburring inspection
  • Final visual inspection
• Document inspection results in accordance with customer procedures and customer expectations
• Document and intercept non-conformances detected during inspection
• Input product data and maintain inventory
• Maintain adequate records of inspections and testing
• Conduct DHR (device history record) and GDP (good documentation practices) review.
• Process non-conforming material reports upon detection of non-conforming material
• Work closely and collaboratively with multiple departments to identify and rectify quality issues
• Perform duties in strict compliance with FDA, QSR, GMP regulations
• Plan, organize, and prioritize own daily work routine to meet expected schedule of deliverables
• Demonstrate ability to resolve a host of quality issues throughout work processes in adherence with company procedures, quality systems standards, and supplier quality agreement

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

• Detail oriented and methodical
• Capable of organizing, prioritizing, and multi-tasking
• Ability to operate standard mechanical measuring equipment such as an optical comparator, micrometer, and calipers
• Ability to read and interpret drawing requirements, perform work to inspection instruction
• Ability to use a microscope

Education and/or Experience

• A High School Diploma or equivalent
• Familiarity with quality inspection procedures, preferably within a manufacturing environment
• Experience in medical device or manufacturing industry, or related field involving and governed by regulatory compliance
• Data entry experience
• Experience with computing, database programs, scanning documents, and word processing
• Ability to work under deadlines
• Familiarity with ISO9001 and ISO13485 requirements preferred
• CMM experience preferred