Senior Consultant - MedTech QMS Complaints
$80k/y-$200k/y
3 days ago
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OnsiteFull-timeSenior
Summary
Veeva Systems is seeking a Senior Consultant - MedTech QMS Complaints to join their team in Minneapolis, MN. The role involves leading MedTech Complaints implementations and guiding the transformation of customers' Complaints Management processes and technology.
About the Role
As a Senior Consultant - MedTech QMS Complaints, you will review and analyze existing customer business processes, lead QMS Complaints implementation workstreams, manage communication between implementation teams and customer stakeholders, and guide customers in adopting Vault and industry best practices for continuous improvement.
About You
Required:
- 8+ years of experience in Project Management, GMP Systems ownership, or Software Consulting.
- 4+ years of experience in Complaints Management for Medical Device.
- Strong understanding of FDA, EU MDR/IVDR requirements and Reporting.
- 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.
- Excellent verbal and written communication skills.
Preferred:
- Veeva Vault implementation experience.
- Management Consulting experience.
- 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.
Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 875 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Canada, Europe, Asia, and Latin America. Visit the Jobs section for open positions and remember that correspondence to new applicants and existing candidates will only come from an official @veeva.com email address.
Minneapolis, MN