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.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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