Remote Senior Manager, Software QA for MedTech

LivaNova; Texas; A distancia; USD 150.000 - 175.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Collaborative work with international/

Opportunities to collaborate with国际伙伴

Descripción de la vacante

LivaNova is seeking a Senior Manager, Software Quality Assurance to lead the software quality function across product software, firmware, and digital health platform services. This role demands strategic leadership, risk management, and hands-on development knowledge to ensure compliance with applicable quality systems.

You and your team will collaborate with R&D, Regulatory, Operations, Security, Marketing, and Clinical to drive continuous improvement and ensure on-time delivery of

Formación

• Engineering degree required with advanced degree preferred.
• Experience with medical device software and quality leadership.
• Solid knowledge of ISO 13485, IEC 62304, FDA QMSR, ISO 14971 and cybersecurity requirements.
• Proven ability to lead complex software investigations, CAPAs and risk assessments.
• Experience with software development for medical devices (C/C++ preferred) and regulatory audits.

Responsabilidades

• Lead the software quality function for product software, firmware and cloud infrastructure.
• Oversee design control, risk management and verification/validation activities.
• Chair software change control boards and manage defect processes; communicate V&V results to leadership.
• Partner with R&D, Regulatory, Operations, Security, Marketing and Clinical teams.
• Own software quality management system and drive continuous improvement in processes and metrics.
• Ensure compliant validation of manufacturing/test software in new product development.
• Support internal audits and regulatory inspections; maintain complete design history files.
• Communicate status, risks and mitigation plans to senior leadership.

Conocimientos

Leadership

Quality assurance

Regulatory knowledge

IEC 62304

Software development

Educación

BS in Computer Engineering, Computer Science, Electrical Engineering, or related field

MS or higher in engineering or software-related discipline preferred

Herramientas

C/C++

Descripción del empleo

LivaNova is seeking a Senior Manager, Software Quality Assurance to lead the software quality function across product software, firmware, and digital health platform services. This role demands strategic leadership, risk management, and hands-on development knowledge to ensure compliance with applicable quality systems.

You and your team will collaborate with R&D, Regulatory, Operations, Security, Marketing, and Clinical to drive continuous improvement and ensure on-time delivery of