Quality Software Engineer I: MES & CSV

Terumo Medical Corporation; Elkton (MD); Presencial; USD 68.000 - 90.000; Jornada completa

Descripción de la vacante

Terumo Medical Corporation in Elkton, MD is seeking a Software Quality Engineer I to support MES deployments, sustaining, and software validation activities within the quality system. This role involves developing validation plans, reviewing validation protocols, executing test cases, and maintaining the electronic device history record (eDHR) to ensure quality and regulatory compliance.

You will collaborate with cross-functional teams to ensure adherence to 21 CFR Part 11, ISO 13485, and GAMP

Formación

• Knowledge of MES and its role in an organization.
• Experience with CSV validation and software validation processes.
• Familiarity with 21 CFR Part 11, ISO 13485 and GAMP 5 guidelines.
• Excellent written and verbal communication; strong attention to detail.

Responsabilidades

• Develops software validation strategies for quality system and manufacturing software.
• Reviews and approves validations, test scripts, and reports.
• Supports continuous improvement of validation and controls processes per regulatory requirements.
• Interprets risk-based techniques for software validation and controls.
• Functions as an MES team member to support deployments, sustaining, and optimization projects.
• Assists with MES validation test case development and S/V activities including CRS revisions and test execution.
• Maintains MES system compliance and the integrity of its validated state and the eDHR.

Conocimientos

Quality Systems knowledge

CSV experience

Documentation & writing

Team collaboration

Educación

Associate’s degree in engineering or scientific discipline

Equivalent combination of education and experience

Herramientas

MS Office

Descripción del empleo

Terumo Medical Corporation in Elkton, MD is seeking a Software Quality Engineer I to support MES deployments, sustaining, and software validation activities within the quality system. This role involves developing validation plans, reviewing validation protocols, executing test cases, and maintaining the electronic device history record (eDHR) to ensure quality and regulatory compliance.

You will collaborate with cross-functional teams to ensure adherence to 21 CFR Part 11, ISO 13485, and GAMP