Senior Quality Engineer, MedTech CSV & QMS

Tempus; Chicago (IL); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Tempus is seeking a Senior Software Quality Engineer to lead the implementation and maintenance of systems supporting the Quality Management System (QMS) and SDLC activities. The role involves CSV activities, testing against user requirements, and supporting design controls for medical device software.

Responsibilities include liaison with vendors, training, UAT testing, and ensuring compliance with 21 CFR Part 11, FDA QSR, ISO 13485, IEC 62304, and related standards.

Formación

• 5+ years in a quality role in FDA/regulatory environments.
• Experience with FDA QSR, ISO 13485, IEC 62304, 21 CFR Part 11.
• Experience with SDLC tools: JAMA, JIRA, eTQ.

Responsabilidades

• Manage and maintain QMS software and SDLC tools.
• Validate regulated software applications per CSV and regulatory requirements.
• Collaborate with software teams to ensure quality deliverables.
• Provide training on Tempus CSV standards and processes.
• Defend validation compliance with internal and external audits.

Conocimientos

Quality assurance

Communication skills

Agile/Scrum

Documentation

Team collaboration

Educación

B.S. in Computer Science or related field

Herramientas

JAMA

JIRA

eTQ

Atlassian

Descripción del empleo

Tempus is seeking a Senior Software Quality Engineer to lead the implementation and maintenance of systems supporting the Quality Management System (QMS) and SDLC activities. The role involves CSV activities, testing against user requirements, and supporting design controls for medical device software.

Responsibilities include liaison with vendors, training, UAT testing, and ensuring compliance with 21 CFR Part 11, FDA QSR, ISO 13485, IEC 62304, and related standards.