Senior Quality Engineer

2 weeks ago


Cleveland, United States BioTalent Full time

BioTalent are proud to represent a world leading Healthcare and Medical Device pioneer on the search for an Senior Quality Engineer to join their renowned site in Mississippi.


They are seeking an experienced Senior Quality Engineer to perform equipment qualification, test method and process validation activities to ensure regulatory compliance at all times.


This role will offer you:

  • A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save lives.
  • A great opportunity to develop your career within a company that provides continuous career and development opportunities.
  • The opportunity to take on more project lines at the site


You will be Responsible for:

  • Driving quality compliance through equipment qualification, test methods and process validation activities
  • Using Lean, problem solving, process control, and project management tools to maintain operational excellence
  • Acting as an SME for CSV Validation processes.
  • Collaborate with cross-functional teams, contractors, and vendors
  • Responsible for investigations and CAPAs
  • Responsible for software validation activities in manufacturing


You will bring the following:


  • Bachelor's Degree in Engineering or Computer Science
  • 3+ years within a similar Quality Engineering role within a highly regulated environment
  • Proficiency in applications such as Wonderware, Allen-Bradley PLC/HMI, Access, Microsoft Project
  • ASQ Certification (CQE or CSQE) or equivalent desired.



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