Remote MedTech QMS Implementation Lead | Consultant

Veeva Systems, Inc.; Chicago (IL); Remote; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Dental vision insurance

Flexible PTO

Retirement programs

1% charitable giving program

Job summary

Veeva Systems is hiring a quality software consultant to lead QMS implementations for MedTech customers globally. You will guide transformation of Quality Management processes and collaborate with Professional Services teams for delivery success.

The role requires GMP systems ownership, regulatory expertise, and strong communication to manage expectations with customers and stakeholders during implementation and post-implementation programs.

Qualifications

• 6+ years of experience in GMP Systems ownership or Software Consulting.
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting.
• Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes.
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11.
• Ability to understand business requirements and design creative solutions.
• Excellent verbal and written communication skills.
• Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces.

Responsibilities

• Lead QMS implementation workstreams for Veeva’s MedTech Quality Management solutions.
• Review and analyze existing customer business processes to identify gaps and requirements that impact implementation approach.
• Function as primary liaison between implementation teams, customer stakeholders, and third parties.
• Analyze customer requirements and product features to develop adoption and enhancement roadmaps.
• Guide customers in adopting Vault and best practices as part of post-implementation programs.

Skills

GMP experience

Software consulting

Regulatory knowledge

Quality Management

Communication skills

Life sciences domain

Problem solving

Tools

Veeva Vault

Job description

Veeva Systems is hiring a quality software consultant to lead QMS implementations for MedTech customers globally. You will guide transformation of Quality Management processes and collaborate with Professional Services teams for delivery success.

The role requires GMP systems ownership, regulatory expertise, and strong communication to manage expectations with customers and stakeholders during implementation and post-implementation programs.