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Engineered Medical Systems, LLC · 3 months ago

Quality Assurance Inspector I

Bartlett, TN

Full-time

Onsite

New Grad, Entry Level

Engineered Medical Systems, LLC is seeking a Quality Assurance Inspector I who will be responsible for inspecting products to ensure they meet customer specifications and quality acceptance criteria. The role involves performing various inspections, maintaining documentation, and supporting compliance with FDA regulations and ISO 13485 requirements.

Machinery ManufacturingManufacturingMedical Device

No H1B

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

Qualification

Inspection equipment usageQuality documentationMath skillsAttention to detailSafety requirementsEnglish proficiencyTeamworkCritical thinking

Required

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