MedTech QMS Implementation Lead (Remote)

Veeva Systems, Inc.; Boston (MA); Hybrid; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and basiclife

Flexible PTO and holidays

Retirement programs

1% charitable giving

Job summary

Veeva Systems, Inc. is seeking an experienced quality software consultant to lead QMS implementations for MedTech customers worldwide.

This role guides the transformation of our customers’ Quality Management processes and technology, working with Professional Services teams to ensure delivery success across implementations. Candidates bring 6+ years in GMP systems ownership or software consulting, plus knowledge of FDA/EU MDR/IVDR, CAPA, NCR, and ISO 13485/14971.

Qualifications

• 6+ years of 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

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions
• Function as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd parties
• Analyze customer requirements and new product features to develop customer adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customer

Skills

GMP Systems

Software Consulting

FDA/regulatory knowledge

CAPA & NCR

ISO 13485 / 14971

Strong communication

Life sciences experience

Job description

Veeva Systems, Inc. is seeking an experienced quality software consultant to lead QMS implementations for MedTech customers worldwide.

This role guides the transformation of our customers’ Quality Management processes and technology, working with Professional Services teams to ensure delivery success across implementations. Candidates bring 6+ years in GMP systems ownership or software consulting, plus knowledge of FDA/EU MDR/IVDR, CAPA, NCR, and ISO 13485/14971.