Quality Systems Manager

Overview

Voltas is seeking a Quality Systems Manager to own, operate, and continuously improve our Quality Management System using Grand Avenue Software
.

This role is hands-on and execution-focused. You will be the internal owner of Grand Avenue Software and responsible for ensuring our QMS supports rapid development while remaining audit-ready for ISO 13485, FDA, and customer audits.

This is not a purely strategic role — you will be in the system daily.

• Grand Avenue Software (Primary Responsibility)
• 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

• 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
• FDA 21 CFR 820
• 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

• 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

• Everything is done in-house — no endless vendor handoffs
• You will have real ownership of the QMS
• Work directly with engineering, manufacturing, and leadership
• Build systems that enable speed, not bureaucracy
• Be part of a growing medical device platform in Minnesota’s Medical Alley