MedTech QMS Lead (Remote)

Veeva Systems; Boston (MA); A distancia; USD 80.000 - 200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

Flexible PTO & holidays

Retirement programs

1% charitable giving program

Descripción de la vacante

Veeva Systems is a mission-driven software leader serving life sciences with Vault and MedTech QA solutions. This role focuses on analyzing customer processes, identifying gaps, and guiding implementation strategies.

You will lead QMS workstreams, act as primary liaison among customers, implementation teams, and third parties, and translate requirements into adoption roadmaps while aligning with FDA/EU requirements and industry best practices.

Formación

• 6+ years of GMP systems ownership or software consulting.
• Strong understanding of FDA, EU MDR/IVDR requirements.
• Understanding of CAPA, Nonconformance and Risk Management processes.
• Knowledge of ISO 13485 and 14971, FDA 21 CFR 803, 820, 822, 806.
• Excellent verbal and written communication skills.
• Experience in Life Sciences Quality, Manufacturing, or Healthcare spaces.

Responsabilidades

• Review and analyze existing customer business processes for implementation.
• Lead QMS implementation workstreams for Veeva’s MedTech Quality Management solutions.
• Function as primary liaison between customers, implementation teams, and 3rd parties.
• Analyze customer requirements and new product features to develop adoption roadmaps.
• Guide customers in adopting Vault and post-implementation continuous improvement.

Conocimientos

GMP Systems ownership

Software Consulting

FDA/EU MDR/IVDR knowledge

CAPA & Risk Management

Excellent communication

Life Sciences QA/Healthcare

Descripción del empleo

Veeva Systems is a mission-driven software leader serving life sciences with Vault and MedTech QA solutions. This role focuses on analyzing customer processes, identifying gaps, and guiding implementation strategies.

You will lead QMS workstreams, act as primary liaison among customers, implementation teams, and third parties, and translate requirements into adoption roadmaps while aligning with FDA/EU requirements and industry best practices.