Quality Assurance Inspector I

Engineered Medical Systems•Bartlett, TN

About The Position

The Quality Assurance Inspector I will be inspecting product to assure that it meets or exceeds the requirements set forth by customer specifications and quality acceptance criteria. Description Perform first article, in-process, and final product inspection using drawings, specifications, and/or related instructions. Read manufacturing prints and determine relevant features for verification of accuracy. Understand and complete Document Review Checklist (DRC and Quality Inspection Report (QIR) accurately. Capture results data and store electronically in correct file folders. Correctly utilize / interpret generalized inspection equipment, to include micrometers, calipers, comparators, and related gages and equipment. Check out and return gages for each inspection. Maintain strict focus on accuracy, neatness, and thoroughness of product inspection and documentation of results. Identify non-conforming product and notify appropriate personnel or management. Record production through Job Boss system. Performs other job duties as assigned. Support of the EMS Quality Policy and Quality Objectives. This team member supports various activities that contribute to the overall EMS objective of compliance to FDA regulations & ISO 13485 requirements. Ongoing collaboration with additional EMS roles is required.

Requirements

A minimum of a High School diploma or general education degree (GED) is required.
General understanding of proper documentation/quality requirements for a regulated environment.
Good math skills.
Works well under pressure.
Ability to think critically and have a strong attention to detail.
Have an understanding of relevant Safety requirements.
Must be able to work in a team environment.
Must be able to speak, read and write in the English language.
Good vision either natural or thru correction (Glasses/Contacts lens) is needed for this position.
Levels of Monochromacy, also known as Color Blindness, must be known to establish appropriate risk for certain types of inspection that are dependent on color recognition.
Able to lift or maneuver tools and material within your scope of responsibility, using or requesting proper and approved maneuvering equipment where necessary.

Responsibilities

Perform first article, in-process, and final product inspection using drawings, specifications, and/or related instructions.
Read manufacturing prints and determine relevant features for verification of accuracy.
Understand and complete Document Review Checklist (DRC and Quality Inspection Report (QIR) accurately.
Capture results data and store electronically in correct file folders.
Correctly utilize / interpret generalized inspection equipment, to include micrometers, calipers, comparators, and related gages and equipment.
Check out and return gages for each inspection.
Maintain strict focus on accuracy, neatness, and thoroughness of product inspection and documentation of results.
Identify non-conforming product and notify appropriate personnel or management.
Record production through Job Boss system.
Performs other job duties as assigned.
Support of the EMS Quality Policy and Quality Objectives.
This team member supports various activities that contribute to the overall EMS objective of compliance to FDA regulations & ISO 13485 requirements.
Ongoing collaboration with additional EMS roles is required.