VOLTAS · 5 hours ago
Quality Systems Manager
Cottage Grove, MN
Full-time
Onsite
Senior Level
5+ years expVoltas is seeking a Quality Systems Manager to own, operate, and continuously improve their Quality Management System using Grand Avenue Software. This role involves hands-on management of the QMS, ensuring compliance with ISO 13485 and FDA regulations while supporting rapid development and audits.
Medical Device
Hiring Manager
Jason Scherer
Responsibilities
Own and administer Grand Avenue Software as Voltas’ electronic QMS
Configure, maintain, and continuously improve workflows for:
Document Control
Design History Files (DHF)
Device Master Records (DMR)
Change Control
CAPA
Complaints
Training records
Ensure accurate, timely, and compliant documentation across multiple active development programs
Train internal teams on proper use of Grand Avenue Software and QMS processes
Maintain compliance with ISO 13485 and FDA 21 CFR 820
Support internal, customer, and regulatory audits (FDA, ISO, MDSAP as applicable)
Drive CAPA investigations, root cause analysis, and effectiveness checks
Support management reviews and quality metrics reporting
Partner closely with R&D, manufacturing, regulatory, and operations teams
Support design control activities throughout development phases
Ensure DHFs are audit-ready at all stages
Support design transfer from R&D to manufacturing
Ensure quality documentation aligns with fast-paced, in-house development and manufacturing
Qualification
Required
5+ years of medical device quality experience
Direct, hands-on experience running an electronic QMS (Grand Avenue Software strongly preferred)
Strong working knowledge of: ISO 13485
Strong working knowledge of: FDA 21 CFR 820
Strong working knowledge of: Design controls, CAPA, complaints, change control
Experience supporting audits and inspections
Comfortable working in a fast-moving, development-focused environment
Detail-oriented, organized, and proactive
Preferred
Experience in vertically integrated medical device companies
Exposure to Class II and/or Class III devices
Experience supporting sterilization, packaging, and manufacturing processes
Prior experience scaling or improving a QMS
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