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Senior Quality Engineer - United States  

Becton Dickinson (company)

Posted on : 12 August 2017

Project Description

Job Description

The Senior Quality Engineer will play a pivotal role in site process improvement activities and operations support for our Dispensing products.   Reporting to the Quality Engineering Manager, duties include: management and approval of process validation studies, active participation in non-conformance investigations and leading process improvement projects.   The role also involves the management of continuous improvement projects, and application of SPC to current production processes.  


  • Drive and maintain cGMP practice within the departments under your quality responsibility.
  • Drive root cause analysis of non conformance with the department subject matter experts.     Preparation, review and approval of technical documentation.
  • Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments.
  • Devise and implement Six Sigma continuous improvement projects.
  • Review, analyse and report on field data (complaints, repairs, etc.)
  • Support and drive key changes and improvements in manufacturing relating to product quality.
  • Carry out Quality and Regulatory Compliance functions within the Quality Engineering Team  


  • Bachelor's Degree in Engineering field.
  • A minimum of 8 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices Industry.
  • Experience in the preparation of Technical Documentation.
  • Supervisory or Project Manager experience.
  • Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).  
  • Experience in CAPA system management.
  • A working knowledge of FDA/ISO requirements and managing FDA/ISO audits.
  • Experience in process validation,.
  • Proven ability of working in a cross-functional team environment.
  • Excellent interpersonal and communication skills and high level of computer literacy.


Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift