MedTech Complaints Lead for QMS Implementations

Veeva Systems, Inc.; Boston (MA); Híbrido; USD 80.000 - 200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision, and basiclife

Flexible PTO and company paid holidays

Retirement programs

1% charitable giving program

Descripción de la vacante

Veeva Systems is seeking an experienced MedTech Complaints consultant to lead QMS Complaints implementations for Veeva’s MedTech customers worldwide. This role will guide the transformation of our customers’ Complaints Management processes and technology, working closely with Professional Services to ensure delivery success across QMS implementations.

You will liaise with customers, analyze requirements, and help adopt Vault and best practices as part of post-implementation programs focused on

Formación

• Experience owning GMP systems or leading software consulting in regulated environments.
• 5+ years in Complaints Management for Medical Device.
• Strong knowledge of FDA and EU MDR/IVDR requirements.
• Understanding of how Complaint Handling links to CAPA, Nonconformance and Risk.
• Familiarity with ISO 13485/14971, FDA 21 CFR 803/820/822/806, EU GMP Annex 11.
• Proven track record leading implementations in a consulting/IT lead role.
• Ability to work independently and in teams in a fast-paced setting.
• Knowledge of SaaS and GxP principles; ability to design practical solutions.
• Excellent written and verbal communication; Life Sciences exposure.
• Experience with Data or Content Management applications.

Responsabilidades

• Lead QMS Complaints implementation workstreams for MedTech customers globally.
• Analyze customer requirements and identify gaps to guide adoption and roadmaps.
• Serve as primary liaison between implementation teams, customers, and third parties.
• Collaborate with teams to develop enhancements and post-implementation improvements.
• Guide customers in adopting Vault and industry best practices post-implementation.

Conocimientos

GMP Systems ownership

Complaints Management (Medical Device)

FDA/EU MDR/IVDR knowledge

SaaS and GxP principles

Communication (verbal & written)

Independent work capability

Life Sciences domain experience

Data or Content Management familiarity

Herramientas

Veeva Vault

Descripción del empleo

Veeva Systems is seeking an experienced MedTech Complaints consultant to lead QMS Complaints implementations for Veeva’s MedTech customers worldwide. This role will guide the transformation of our customers’ Complaints Management processes and technology, working closely with Professional Services to ensure delivery success across QMS implementations.

You will liaise with customers, analyze requirements, and help adopt Vault and best practices as part of post-implementation programs focused on