Senior Consultant - MedTech QMS Complaints jobs in United States
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Veeva Systems · 9 hours ago

Senior Consultant - MedTech QMS Complaints

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. They are seeking an experienced consultant to lead MedTech Complaints implementations, guiding the transformation of customers’ Complaints Management processes and technology while ensuring delivery success across QMS implementations.

BiotechnologyCRMEnterprise SoftwareSoftware
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H1B Sponsor Likelynote

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

Qualification

GMP Systems ownershipComplaints ManagementFDA requirementsISO 13485 knowledgeSaaS understandingChange ManagementManagement ConsultingCommunication

Required

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, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business 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

Preferred

Veeva Vault implementation experience
Management Consulting
Change Management experience
Field Action and Product Return experience
Clinical Medical Device, Biologics, and SaMD experience

Benefits

Medical, dental, vision, and basic life insurance
Flexible PTO and company paid holidays
Retirement programs
1% charitable giving program

Company

Veeva Systems

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Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry.

H1B Sponsorship

Veeva Systems has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (60)
2023 (52)
2022 (73)
2021 (55)
2020 (38)

Funding

Current Stage
Public Company
Total Funding
$7M
Key Investors
Emergence Capital
2013-10-16IPO
2008-06-05Series Unknown· $4M
2007-02-06Angel· $3M

Leadership Team

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Peter Gassner
Founder and CEO
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Mitch Wallace
Retired - Co-Founder and VP Operations
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Company data provided by crunchbase