Senior MedTech QMS Complaints Consultant

Veeva Systems, Inc.; Minneapolis (MN); On-site; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Flexible PTO & holidays

Retirement programs

1% charitable giving

Job summary

Veeva Systems, a mission-driven SaaS leader in life sciences, seeks an experienced MedTech Complaints consultant to drive QMS implementations for global customers. You will guide transformation of complaints management processes and collaborate with Professional Services to ensure delivery success across implementations.

You will liaise with customers and internal teams, analyze requirements, and shape adoption roadmaps while promoting Vault-driven best practices in post-implementation programs

Qualifications

• 8+ years of experience in GMP Systems ownership or Software Consulting.
• 5+ years of experience in Complaints Management for Medical Device.
• 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, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11.
• Proven track record leading implementation and IT operations as a consultant, business analyst, or IT lead/sponsor.
• Proven ability to work both independently and in teams in a dynamic, fast-moving environment.
• Good understanding of SaaS and GxP principles.
• Ability to quickly understand business requirements and design creative solutions; excellent verbal and written communication skills.
• Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces.
• Experience with Data or Content Management applications.

Responsibilities

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach.
• Lead QMS Complaints 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

Complaints Management

FDA/EU MDR/IVDR

CAPA & Risk

ISO 13485/14971

IT Project Leadership

SaaS & GxP

Requirements Analysis

Communication Skills

Life Sciences Experience

Data / Content Management

Independent / Team Work

Tools

Veeva Vault

Job description

Veeva Systems, a mission-driven SaaS leader in life sciences, seeks an experienced MedTech Complaints consultant to drive QMS implementations for global customers. You will guide transformation of complaints management processes and collaborate with Professional Services to ensure delivery success across implementations.

You will liaise with customers and internal teams, analyze requirements, and shape adoption roadmaps while promoting Vault-driven best practices in post-implementation programs