VOLTAS · 13 hours ago
Quality Manager
St Paul, MN
Full-time
Onsite
Senior Level
5+ years expVoltas is a vertically integrated medical device development and manufacturing company based in Minnesota, focused on reimagining the future of medical device development. They are seeking a Quality Manager to own and elevate their Quality Management System, ensuring product safety and compliance while supporting innovation.
Medical Device
Hiring Manager
Patrick Hodgdon
Responsibilities
Own and continuously improve the Voltas Quality Management System (QMS) in compliance with FDA, ISO 13485, and applicable global standards
Ensure quality is embedded across the entire product lifecycle—from design and development through manufacturing and commercialization
Lead internal and external audits, including FDA inspections and notified body audits
Drive CAPA, nonconformance, risk management, and change control processes with clarity and urgency
Partner with Engineering and Manufacturing to support design controls, process validation, and supplier quality
Establish scalable quality processes that support growth without introducing unnecessary friction
Train and empower teams across Voltas to understand, own, and execute quality responsibilities
Act as a key voice in leadership discussions, helping balance speed, compliance, and long-term reliability
Build trust—with regulators, customers, partners, and internal teams
Qualification
Required
5+ years of experience in Quality roles within medical device or highly regulated industries
Hands-on experience owning or managing a QMS
Strong knowledge of FDA QSR, ISO 13485, and design controls
Experience supporting audits and inspections
A bias toward action, clarity, and accountability
Preferred
Startup, scale-up, or vertically integrated manufacturing experience is a strong plus
Company
VOLTAS
From prototype to procedure, Voltas keeps every phase of development connected, powered, and moving forward — eliminating hand-offs and accelerating time to market.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase