- Maple Grove, Minnesota
- Pharma & Biotech, Medical Devices, Engineering, Engineering & Validation, Quality Assurance (QA), Operations, Regulatory Affairs (RA), Engineering, Test and Verification
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.
- 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.