Connecting...

Quality Engineer

Position Summary:

The Quality Engineer will execute Blood Product quality validations concerned with development and manufacturing. Assist in quality development and review of specifications, manufacturing procedures, plans, protocols, reports. Quality review/release of blood products.

Responsibilities:

  • Drafting/writing of plans, protocols and reports for development to support qualification of blood products and associated items
  • Perform characterization and validation studies for new blood products and assists in review of development data
  • Assist in test method validation, as needed
  • Collaborates on critical manufacturing related processes and decisions
  • Assesses proposed changes to blood product specifications, processes and procedures for impact related to product approvals/qualifications
  • Follows company policies and procedures
  • Investigates deviations from procedures and specifications related to development and manufacturing of blood products and provides input for appropriate corrective actions
  • Partners with manufacturing to solve issues/problems that may occur
  • Partners with Quality Systems in supplier management activities
  • Supports Annual Product Review activities, as needed
  • Other duties as assigned

Sthree US is acting as an Employment Business in relation to this vacancy.