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Quality
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181797 Requisition #
Thanks for your interest in the Quality Engineer III position. Unfortunately this position has been closed but you can search our 420 open jobs by clicking here.
Minimum Requirements
 
The following listed requirements need to be met at a minimum level to be considered for the job:
  • Support Risk Management Activities: Update existing risk analyses as needed from Non-conformance Reports, Complaints, Sr. QE projects, etc.
  • Review and approve validation documents in BRAM system, including remote off-shift review as required.
  • Complete CAPAs/NCR’s/ECO’s as required.
  • Review and approve documents under Change Control ensuring compliance with GMP, GDP, GTP, and regulatory standards such as ISO13485, 21CFR820, ISO14971, etc.
  • Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc.  Update risk management file documents as needed.
  • Provide Quality support on project work and lead projects related to core production while ensuring compliance with Design Controls and applicable regulations/standards. Challenge the approach and provide innovative alternative solutions to protocol designs.
  • Perform product impact / risk assessments for nonconformances, CAPAs, ECOs. Etc.
  • Recommend enhancements / continuous improvement of the QMS.
Additional Requirements and Education:
The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.
  • Bachelor’s degree required in Engineering or Science
  • Minimum 7 years of Quality Assurance/Quality Engineering/Engineering/Operations experience.
  • Validation lifecycle experience.
  • Risk Management 
  • CAPA lifecycle experience, including root cause investigation
  • 21CFR820 and 1271
  • AATB knowledge preferred but not required
  • Technical writing
  • Basic statistics
  • Presentation and communication skills
  • GMP, GDP, GTP understanding
  • Change Control experience
  • Audit support experience helpful, but not required
  • Certified Quality Engineer (CQE) preferred
  • Ability to train and motivate in area of compliance and quality improvement.

 

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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