Engineer, Quality

Below is a sample job description for the contract job opportunity at Abbott:

OVERVIEW

• The purpose of this position is to initiate medical device quality assurance activities. 
• These activities must be in accordance with FDA Quality System Regulations, ISO13485 and other international standards. 
• This position will also support device complaint investigation and failure analysis as required.

KEY ACCOUNTABILITIES

• Develop incoming inspection processes and document incoming inspection activities.  
• Provide in-process QA support to include inspection and document review.   
• Complete final acceptance activities.   
• Track nonconforming material and lead Material Review Board (MRB) efforts.  
• Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies, and contract processing.  
• Manage corrective action and quality improvement activities.   
• Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. 

QUALIFICATIONS

• Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred). 
• 5+ years technical experience. 
• Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies. 
• Detailed knowledge of FDA, GMP, and ISO 13485. 
• Prior medical device experience preferred; ASQ CQT, CQE, CQA certification preferred. 
• Six Sigma root cause analysis/problem solving training and experience preferred. 
• Ability to travel approximately 10%, including internationally. 

Associated Job Titles: Engineer Sr., Quality, Development Quality Engineer, Quality Engineer I-IV

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to performing the key duties that create life-changing breakthroughs.