Quality Control Technician II

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Summary:

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 storge/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
• Travel between ZELTIQ locations as needed.
• Must be available to work overtime as requested by supervisor.  This may include nights, weekends, and holidays during times critical to our business.
• Identify areas for Quality Control Improvements
• Any other tasks assigned by the supervisor.

Qualifications

Qualifications:

• 5 plus years’ experience in quality inspection/release, preferably in FDA regulated industry.
• Electromechanical component inspection experience required.
• Must have a solid understanding of MS Office applications such as Outlook, Word, and Excel

Additional Requirements:

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

 

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.