AbbVie

Quality Analyst

Employer
AbbVie
Location
Dublin, CA, United States
Posted
Nov 09, 2020
Ref
203810
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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:

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.

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, 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.