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Engineered Medical Systems, LLC · 3 months ago

Quality Assurance Inspector II

Bartlett, TN

Full-time

Onsite

Entry Level

2+ years exp

Engineered Medical Systems (EMS) is a full-service medical device manufacturer dedicated to precision, innovation, and quality. The Quality Assurance Inspector II will be responsible for inspecting products to ensure they meet customer specifications and quality acceptance criteria, supporting compliance with FDA regulations and ISO standards.

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. May be involved in inspecting parts using advanced inspection equipment

Check out and return gages for each inspection

Assist with customer concerns and inquiries as they relate to product quality at EMS

Assist and / or instruct manufacturing personnel with checking product correctly as it relates to the customer inspection criteria

Maintain strict focus on accuracy, neatness, and thoroughness of product inspection and documentation of results

Identify non-conforming product and may complete or escalate to management non-conforming paperwork and product per requirements

Record production through Job Boss system

Performs other job duties as assigned

Support of the EMS Quality Policy and Quality Objectives

Qualification

Quality inspection experienceFDA regulations knowledgeISO 13485 standardsDocumentation skillsAttention to detailMath skillsSafety requirements understandingEnglish language proficiencyTeamworkCritical thinking

Required

A minimum of a High School diploma or general education degree (GED) with 2+ years of inspection or machining experience or an equivalent combination of education and experience is preferred

Some prior quality inspection experience is required

Experience in proper documentation/quality requirements for a regulated environment

Understanding of FDA and global regulations and standards (including guidance documents), ISO, GMP, and ASTM applicable standards related to validation and equipment controls

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