Senior Quality Engineer

Cleveland, Ohio, United States

Posted on 07/11/2019

Position Details




Healthcare / Medical Supply



Job Level:

Experienced Professional (Non-Manager)


Bachelor's Degree

Reference ID:


Exciting Engineering Opportunity!


Senior Quality Engineer – Medical Device


Come join this well-established Fortune 500 Company as they continue to lead the Medical Device industry in technology, manufacturing, Engineering and Design.


Essential Duties and Responsibilities

  • Responsible for the scheduling of sterilization services in house and with Contract Sterilizers.
  • Responsible for sterilization qualification and requalification scheduling and execution of studies.
  • Responsible for scheduling and execution of temperature mapping studies across the facility.
  • Must perform process validation, process capability, and process control studies for assigned areas.
  • Must drive quality/manufacturing projects utilizing Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
  • Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technology.
  • Analyze and assess current systems to assure regulatory compliance.
  • Facilitate the validation status of key process equipment.
  • Plan and prioritize multiple projects to ensure completion within the target dates.
  • Perform failure investigations and track follow-up corrective actions as indicated.
  • Must assist in the identification and development of process improvement projects including automation and computerization.
  • Responsible for ensuring FDA regulations are met for system upgrades/replacements.
  • Ability to function effectively as a member of a team.
  • Ability to communicate effectively in written and verbal form.
  • Responsible for Specification/SOP compliance for sterilization processes (EO, gamma, steam)
  • Evaluate and assist in ways to improve supplier and plant processing characteristics to improve the quality and cost of sterilized products.
  • Support and assist in activities to assure products’ sterility is maintained.
  • Responsible for Quality management activities in supporting the plant unreleased and released sterilized products.
  • Must perform other duties and responsibilities as determined by supervision/management.
  • Must have knowledge of both plant and departmental environmental health and safety regulations and comply with said regulations accordingly.
  • Some Travel required.



  • BS degree in Engineering Discipline and 3-5 years related experience
  • Ability to work with a diversified cross functional team across within and outside the facility.
  • Meet visual acuity requirements as documented in the Company Visual Acuity Procedure CL-01-01-037.
  • Knowledge of applications such as Wonderware, Allen-Bradley PLC, Microsoft Project preferred.
  • Sterility Assurance or Pharmaceutical industry experience desired
  • Previous experience desired with EO, Gamma Irradiation, and/or Steam Sterilization
  • ASQ Certification (CQE or CSQE), Green Belt Certification, Black Belt Certification or equivalent desired.
  • BS degree in Engineering Discipline and 3-5 years related experience


Please contact Kevin Elliott for more details. (817) 857-7713