Job Title: VP of Operations

Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced VP of Operations to lead and scale all aspects of operations, including manufacturing, supply chain, logistics, and quality, within a regulated medical device or healthcare environment. This executive role is responsible for driving operational efficiency, building high-performing teams, and ensuring compliance with industry standards as the organization expands nationally and globally.

Responsibilities:

• Lead end-to-end manufacturing operations, focusing on production planning, capacity management, and process optimization to support organizational growth.
• Drive operational efficiency and scalability across multiple geographies, ensuring alignment with business objectives.
• Build, mentor, and manage a high-performing operations team, establishing clear accountability and key performance indicators.
• Oversee the entire supply chain, including vendor sourcing, procurement, device kitting, distribution, and returns management.
• Implement scalable fulfillment workflows and manage relationships with manufacturers, logistics providers, and component suppliers.
• Maintain and enhance the Quality Management System (QMS) in compliance with FDA and ISO standards, overseeing CAPA, change control, and complaint handling processes.
• Drive audit readiness, lead internal and external inspections, and foster a culture of quality and continuous improvement.
• Serve as a key member of the leadership team, contributing to strategic planning, operational infrastructure development, and monitoring/reporting of operational KPIs.

Qualifications:

• 7–10 years of progressive operations leadership experience in medical device, healthcare technology, or a regulated industry.
• Demonstrated expertise across manufacturing, supply chain, and quality operations.
• Strong knowledge of QMS frameworks, CAPA, and complaint handling processes.
• Proven track record of building and scaling operations teams in high-growth environments.
• Experience with ERP/inventory systems such as NetSuite, SAP, or similar platforms.
• Experience in FDA-regulated environments (21 CFR Part 820) and/or ISO 13485 preferred.
• Background in scaling device distribution at clinic, distributor, or direct-to-patient levels preferred.
• Startup or early-stage company experience and prior P&L or budget ownership preferred.

Published Category: Manufacturing & Technical Operations