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Quality Engineer III

  • Date Posted September 11, 2020
  • Location Memphis, Tennessee
  • Job Type Contract
  • Job ID 16258

Quality Engineer III

Our global medical device client is looking for a quality engineer to work on a 1-year project providingengineering floor support for production area to ensure production is able to expand capacity and volumes. Document, evaluate, and disposition any nonconformances associated with production.

Responsibilities:

  • Support receiving inspection and in process inspection personnel. Enable optimization of any inspection efficiencies. Document, evaluate, and disposition any nonconformances identified during inspection.
  • Document, evaluate, and record process validation protocols, testing, and reports for process optimization related to current production and future production of new designs.
  • Initiate, identify root cause, evaluate, and document corrective and preventive action following the Quality Management System requirements for CAPA.
  • Complete inspection and evaluation of finished products in pre-sterile quarantine, post-sterile quarantine, and finished goods kitting locations. Ensure full conformance to specification requirements.
  • Assist in the transfer of production activities to a 2nd manufacturing location to enable increased production capacity. Ensure conformance to requirements for all manufacturing locations.
  • Ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team; 10%

Requirements:

  • Travel Some travel required
  • Education Bachelor's degree in Engineering.
  • Minimum 3-5 years in Medical Device / Biologics / IVD manufacturing experience.
  • Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485

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