MedTech Quality QMS Lead - Remote

Openkrill; United States; Remote; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Flexible PTO

Retirement programs

1% charitable giving

Job summary

Veeva Systems is seeking an experienced quality software consultant to lead QMS implementations for MedTech customers worldwide. You will guide the transformation of customers' Quality Management processes and technology, working closely with Professional Services to ensure delivery success across QMS implementations.

Responsibilities include leading QMS workstreams, liaising with customers and third parties, and shaping adoption roadmaps while applying best practices with Vault.

Qualifications

• 6+ years of experience in GMP Systems ownership or Software Consulting.
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting.
• Understanding of relation between Complaint Handling, CAPA, Nonconformance and Risk Management.

Responsibilities

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

Skills

GMP Systems ownership

Software Consulting

Regulatory knowledge

ISO 13485 / 14971 knowledge

Excellent communication

Life Sciences domain experience

Job description

Veeva Systems is seeking an experienced quality software consultant to lead QMS implementations for MedTech customers worldwide. You will guide the transformation of customers' Quality Management processes and technology, working closely with Professional Services to ensure delivery success across QMS implementations.

Responsibilities include leading QMS workstreams, liaising with customers and third parties, and shaping adoption roadmaps while applying best practices with Vault.