Senior Quality Engineer: Sterility & Environmental Controls

Owens & Minor; Richmond (VA); Vor Ort; USD 100.000 - 120.000; Vollzeit

Zusammenfassung

Owens & Minor seeks a Quality Engineer III specializing in sterility assurance and environmental controls to support medical product sterilization processes. You will lead technical projects, evaluate validation data, and collaborate with cross-functional teams to ensure compliance with Quality systems and regulatory standards.

The role emphasizes technical leadership, supplier and facility audits, and continuous improvement of sterilization processes to ensure product safety and performance

Qualifikationen

• Bachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality, or a related scientific or technical discipline.
• 5+ years of experience in terminal sterilization, sterility assurance, microbiology, or related Quality Engineering.
• Experience developing and executing sterilization validation and qualification activities for medical products.

Aufgaben

• Provide technical expertise in terminal sterilization, sterility assurance, environmental controls, and related Quality-system requirements.
• Develop and execute sterilization validation plans involving EO, gamma, and electron-beam technologies.
• Support product and process changes by evaluating sterilization requirements and risk.
• Develop and maintain sterilization-process specifications and validation documentation.
• Lead defined projects within Sterility Assurance and Environmental Controls.

Kenntnisse

Sterilization

Sterility assurance

Quality engineering

Regulatory compliance

Root-cause analysis

Ausbildung

Bachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality, or related

Tools

Ethylene oxide

Gamma irradiation

Electron-beam irradiation

Jobbeschreibung

Owens & Minor seeks a Quality Engineer III specializing in sterility assurance and environmental controls to support medical product sterilization processes. You will lead technical projects, evaluate validation data, and collaborate with cross-functional teams to ensure compliance with Quality systems and regulatory standards.

The role emphasizes technical leadership, supplier and facility audits, and continuous improvement of sterilization processes to ensure product safety and performance