Quality Engineer

24 hours ago


Jacksonville, Florida, United States Pentangle Tech Services | P5 Group Full time

Technical/Functional Skills

  • experience in a Quality Engineering role within Medical Device11
  • Experience working in a Supplier Quality or Continuity environment
  • Working understanding of QSR/ISO regulations, design assurance, FMEA, Process Flow, and product testing methods.
  • Experience in process validations: creating, reviewing, and approving protocols and reports, and execution of protocols.
  • Experience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA.
  • Experience in pFMEA, manufacturing process flows, control plans, and quality records are required.
  • Expert knowledge of blueprint reading and geometric dimensioning and tolerancing
  • Knowledge of statistics, manufacturing process control and validation, and process capability
  • Medical device manufacturing experience
  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
  • Ability to deliver, meet deadlines and have results orientation.
  • Able to communicate both orally and in written form to multiple levels of the company.
  • Microsoft Office Suite Experience

Generic Managerial Skills

  • Good Documentation Skills.
  • Must have very good written and verbal communication skill.

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