Quality Assurance Specialist
Core
Manage and coordinate the Quality Management System for Gamma Irradiator Systems, Cobalt-60 sealed sources, and Dosimetry Services.
Role type
Quality Assurance Specialist (Nuclear Energy Worker)
Builds
Gamma irradiation systems, Co-60 sealed sources, and dosimetry services
Domain
Healthcare sterilization and nuclear energy
Required skills
ISO 9001, ISO/IEC 17025, non-conformance management, change control, deviation management, corrective action, supplier quality audits, engineering drawing practices, validation activities
Preferred skills
ISO 13485, CSA N299, CNSC, US NRC, CE mark regulations, internal quality audits
Technologies
ISO 9001, ISO/IEC 17025, ISO 13485, CSA N299
Responsibilities
Ensure Nordion meets performance targets and regulatory obligations; Administer non-conformance, complaints, change control, deviation, and corrective action systems; Provide quality oversight for design, manufacturing, and installation of sealed sources and gamma irradiation systems; Provide quality oversight for dosimetry services to conform to ISO/IEC 17025; Connect with supplier quality and manufacturing representatives to ensure component quality; Review Engineering and Manufacturing investigations of non-conformances and complaints.
Seniority
Mid-level, hands-on IC