Quality Analyst

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:

Work with the Quality Engineering and other operations departments to document failures and nonconformances of medical devices, manufacturing equipment/fixtures & components.

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

• Work with cross functions to ensure that non-conformances and deviations are accurately and properly initiated.
• Follow up with Quality Engineering, Supplier Quality Engineering, Manufacturing & Process Engineering to ensures NCMRs are closed timely and properly.
• Manage non-conforming material movements in MRB and complete transactions in ERP system.
• Track and trend Non-Conformance and other Quality Metrics
• Maintain and update NCMR Log and NCMR file
• Participate in quality process improvement projects/initiatives

Other Duties and Responsibilities:

• Process documentation and perform material dispositions
• Handle SAP Transactions of all Non-conforming materials
• Generate and present NCMR Graphs and Reports to Material Review Board (MRB) and Tier meetings

Qualifications

Additional Requirements:

• Minimum of 5 years of experience working in QC/QA environment in a regulated industry (Pharma/Medical Device/Biotechnology/Life Sciences)
• Working Knowledge of QSR and ISO 13485.
• Proficient with Microsoft tools (Word and excel)
• Experience working with Non-conformances, CAPAs, or complaint investigations
• A minimum of 2 years experience working in cGMP environment
• Experience with Non-conforming or CAPA management in an electronic system is strongly preferred

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.

Language and Verbal Skills:

Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Math Skills:

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical and Reading Skills:
Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings .

Physical Requirements:

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry.

Work Environment:

Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

Safety:

Zeltiq is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Significant Work Activities
Continuous sitting 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.