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Quality Inspector III (Medical Device MFG)

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Naples, FL
Job Type
Direct Hire
Jun 23, 2017
Job ID
JOB TITLE: Quality Inspector III

Performs technical quality inspection work. Performs inspections on customer
products to ensure that they conform to specifications. Performs process validation measurements to
include gage R&R and capability studies. Work is performed under general supervision with limited
latitude. Position exercises some judgment in accordance with well-defined policies, procedures, and


Conducts and documents first article, in-process, and finished product inspections to determine
if products are in compliance with order specifications; notifies the Production department

: Tags and isolates non-conforming parts; notifies the Quality Control Manager and operator(s)
: Writes non-conformance reports ensuring compliance with applicable rules and regulations
: Performs process validation measurements to include gage R&R and capability studies; reviews
raw material listed on travelers
: Records test data applying statistical quality control procedures
: Evaluates data to identify deviations from specifications
: Recommends modifications to existing quality and production specifications to achieve optimal
quality within the limits of equipment capability
: Understands and works toward Quality objectives and cost containment; continually optimizes
the inspection process by identifying Quality bottlenecks that hinder production
: Writes work instructions as required
: Assists with the Material Review Board (MRB), QA Final Release, and processing Engineering
Change Orders (ECO's)
: Assists other departments with quality inquiries
: Assists with training of new inspectors
: Performs customer label approval prior to packaging/shipping
: Verifies and approves first piece laser markings
: Coordinates job priorities and arranges inspections for other inspectors accordingly
: Assists Quality Manager as needed
: Assists Quality Engineer with validations and other special requirements
: Provides back up for Quality Manager when away or out of the office

High school diploma or GED; technical certificate preferred; supplemented by Five or more year's
experience in quality inspections in a mid to heavy manufacturing environment; or an equivalent
combination of education, certification, training, and/or experience.

: Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job
: General knowledge of CMM operation, measuring tools, including but not be limited to, calipers,
micrometers, depth gages, indicators, and plug and tread Go/No Go gages; may be trained on the
: Skilled in the use computer software including but not limited to Microsoft Outlook, Word, and
Excel and Visual Enterprise Resource Planning (ERP) software
: Skilled in basic math including but not limited to adding, subtracting, multiplication, division,
geometric construction, practical algebra and metrics for the purpose of calculating material
: Skilled in setting priorities that move projects through efficiently to achieve customer and quality
: Skilled in working independently and following through with assignments with minimal supervision
: Ability to read blueprints
: Good comprehension of Geometric Dimensioning and Tolerancing
: Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
: Ability to learn and adapt to changing technology
: Ability to clearly communicate and understand information in English, both orally and in writing

No sponsorship visa (H1-B, etc) candidates at this time, sorry.
Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:
Phil Montoya
Director of Sourcing
3735 SW 8th Street, Suite 205
Miami, FL 33134
P: 832-266-1610
Fax: 305-520-0138
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