Quality Assurance Quality Control (QA-QC) Inspector II

Company: AbbVie

Type: 12 Month Contract

Swing Shift: 12:00 PM-8:30 PM

Pay: $29.00/hr

We are seeking a Quality Assurance Quality Control (QA-QC) Inspector II for a very important client

Responsible for the inspection and release of all incoming materials and final product including review of records and

inspection of materials and product in compliance with specifications and procedures.

Essential Duties and Responsibilities include the following (other duties may be assigned.):

 - Inspect items for dimensional accuracy, functional operation and cosmetic standards according to drawings, quality procedures, other standards and specifications, using measuring instruments and devices as required per established AQL levels.

- Perform transactions in the ERP system as required and route material for storage/distribution

- Inspect and verify the product and documentation to release final product for shipment. Identify and record product or documentation quality issues.

- Issue nonconformance reports as necessary and work with quality engineers on resolution

- Audit manufacturing line, workstations and quarantine areas to ensure compliance to requirements.

 - Assist in maintenance and coordination of calibration system

- Scanning and filing records

- Identify areas for Quality Control Improvements

- Any other tasks assigned by the supervisor.

- Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR),

ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements

with which ZELTIQ complies.

The ideal candidate will possess the following qualifications:

Travel between ZELTIQ locations as needed

Must be available to work overtime as requested by the supervisor. This may include nights, weekends, and holidays during times critical to our business

Qualifications:

High School Diploma, GED, or equivalent background

2 plus years’ experience in quality inspection/release, preferably in an FDA regulated industry

Electromechanical component inspection experience required

Experience with common measurement and testing tools and equipment and able to lift 42 lbs

Must have a solid understanding of MS Office applications such as Outlook, Word and Excel

2 plus years’ experience in quality inspection/release, preferably in an FDA regulated industry

Additional Requirements:

 Able to read and understand Device History Records, drawings, specifications and reports.

What are the top 3-5 skills requirements should this person have?

· 2 plus years’ experience in quality inspection/release, preferably in an FDA regulated industry

· Electromechanical component inspection experience required

· Experience with common measurement and testing tools and equipment and able to lift 42 lbs

· 2 years GD&T basis experience