Quality Engineer

4 weeks ago


Bonita Springs, United States Tyber Medical LLC Full time

Supports Quality Management System elements across the organization including but not limited to the following areas: CAPA, Control of Nonconforming Material, Quality Events, Process Validation and Supplier Quality.

Requirements

  • Support continuous improvement of quality system processes and procedures, including developing and maintaining Standard Operating Procedures (SOPs).
  • Support other QMS areas as needed, including but not limited to: internal and external audit support; training development and management; CAPA investigations, corrective actions and effectiveness checks.
  • Coordinate development and change control activities product quality plans, inspection forms (FAI, in-process, and final QC), methods of manufacturing, item master, inspection rules, and other documents as needed.
  • Support process validation activities.
  • Support supplier onboarding activities.
  • Support dose audit activities.
  • Support manufacturing site inspections and audits as needed.
  • Support complaint and nonconforming product investigations as needed.
  • Perform internal and supplier audits as needed.


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