Operations & Quality Systems Manager

We are seeking a highly organized and execution-focused Operations & Quality Systems Manager to own the day-to-day operational backbone of AION. This individual will play a critical role in scaling our device logistics, managing vendor relationships, maintaining inventory accuracy, and supporting our quality management system (QMS).

This is a hands-on role for someone who thrives in a fast-paced, high-growth environment and can operate across operations, supply chain, and quality.

Location

Commutable distance to Lowell, MA.

Key Responsibilities:

Operations & Logistics

• Manage end-to-end device logistics including procurement, kitting, distribution, and returns
• Coordinate shipments to clinics, distributors (e.g., McKesson, Cencora), and potentially direct-to-patient programs
• Optimize fulfillment workflows to support rapid scaling across multiple geographies
• Monitor operational KPIs (order accuracy, delivery timelines, device utilization)

Inventory Management

• Maintain accurate inventory tracking across warehouses, distributors, and internal systems
• Implement and manage inventory control processes (cycle counts, reconciliation, forecasting)
• Partner with finance on inventory valuation and reporting
• Prevent stockouts and overstock through proactive planning

Vendor & Supply Chain Management

• Manage relationships with key vendors including manufacturers, logistics providers, and component suppliers
• Track vendor performance (quality, cost, delivery timelines)
• Support sourcing and onboarding of new vendors as we scale
• Ensure vendors meet AION’s quality and regulatory requirements

Quality System Support (QMS)

• Support and maintain AION’s Quality Management System in compliance with FDA and ISO standards
• Own document control processes (SOPs, work instructions, change control)
• Manage and track CAPAs (Corrective and Preventive Actions)
• Lead investigations into product complaints, deviations, and non-conformances
• Support internal audits and external inspections

Product & Field Issue Management

• Triage and investigate product issues reported from the field
• Coordinate cross-functional root cause analysis with engineering, manufacturing, and clinical teams
• Ensure timely resolution and documentation of all issues
• Identify trends and proactively recommend improvements

Qualifications:

Required

• 5 years of experience in operations, supply chain, or quality within medical device, healthcare, or regulated industry
• Experience working within a Quality Management System (QMS)
• Strong understanding of CAPA, change control, and complaint handling processes
• Experience with inventory management systems and operational tracking tools
• Exceptional organizational skills and attention to detail
• Ability to operate both strategically and hands-on

Preferred

• Experience with FDA-regulated environments (21 CFR Part 820) and/or ISO 13485
• Experience supporting device distribution at scale (clinics, distributors, or direct-to-patient)
• Familiarity with ERP or inventory systems (e.g., NetSuite, SAP, or similar)
• Startup or high-growth company experience

What Success Looks Like

• Seamless, scalable logistics supporting thousands of patients
• Accurate, real-time visibility into inventory across all channels
• Strong vendor performance and cost control
• A well-maintained, audit-ready quality system
• Rapid, structured resolution of product and field issues

Why This Role Matters

This role sits at the core of AION’s ability to scale. As we expand nationally and globally, operational excellence and quality rigor will directly impact patient outcomes, customer experience, and regulatory success.

Why Join AION Biosystems

• Play a foundational role in shaping a new category within healthcare.
• High-impact position within a rapidly expanding healthcare technology company.
• Competitive compensation and performance incentives.
• Opportunity to directly influence patient safety and hospitalization outcomes in vulnerable populations.

Work Location: In person