Russell Solutions Group
About This Opportunity
Inquis Medical is seeking an exceptional Vice President of Operations to lead our manufacturing operations, supply chain, and distribution network as we scale our innovative medical device solutions. This is a pivotal leadership role for a proven operations executive who thrives in high-growth environments and has deep expertise in medical device manufacturing.
You'll have the opportunity to build and scale operations from the ground up, establish manufacturing partnerships, implement robust MRP systems, and create distribution networks that will support our company's ambitious growth trajectory.
What You'll Do
Manufacturing & Production Leadership
Develop and implement scalable manufacturing strategies for multiple Class II disposable sterile medical devices
Establish strategic manufacturing partnerships or build internal production capabilities
Design and optimize production workflows ensuring quality, efficiency, and regulatory compliance
Oversee sterile packaging and device sterilization processes
Implement lean manufacturing principles and drive continuous improvement initiatives
Supply Chain & Systems Development
Build comprehensive Material Requirements Planning (MRP) systems from inception using NetSuite
Establish and manage supplier relationships and vendor qualification processes
Develop sophisticated inventory management strategies for raw materials, components, and finished goods
Create demand forecasting models and production planning processes
Implement supply chain risk management and business continuity plans
Quality & Regulatory Excellence
Ensure all manufacturing processes comply with FDA regulations for Class II medical devices
Maintain ISO 13485 quality management system standards
Oversee comprehensive quality control and quality assurance programs
Support regulatory submissions and FDA interactions
Distribution & Logistics
Design and build product distribution network and fulfillment capabilities
Develop warehousing and logistics strategies including facility planning
Implement traceability systems for lot tracking and recall procedures
Create customer service and technical support frameworks
Team Leadership & Organizational Development
Build and lead cross-functional operations teams including manufacturing, facilities, supply chain, and logistics
Establish organizational structure and operational processes
Develop talent acquisition strategies for critical operational roles
Foster a culture of operational excellence and continuous improvement
Financial Management & Strategy
Develop operational budgets and cost models
Implement cost reduction initiatives while maintaining quality standards
Establish key performance indicators (KPIs) and operational metrics
Support financial planning and investor reporting requirements
What You Bring
Education & Certifications
Bachelor's degree in Engineering, Operations Management, or related field (required)
MBA or advanced degree (preferred)
Professional certifications such as ASQ, APICS, or PMP (plus)
Experience Requirements
10+ years
of operations leadership experience in the medical device industry Previous VP of Operations role in a medical device startup (strongly preferred) Proven track record scaling manufacturing operations for Class II medical devices Experience with single-use disposable sterile medical device production Experience in startup or high-growth environments Experience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485 compliant quality systems Demonstrated success building MRP systems and supply chain operations from early stage Experience with direct-to-hospital sales and distribution models Required Skills & Abilities Deep knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards Proven ability to build and scale operations teams Thorough knowledge of materials and production scheduling systems, MRP, and cycle counting Experience working within FDA/ISO regulated environments Experience managing departmental budgets and P&L responsibility Experience complying with environmental health and safety regulations Demonstrated proficiency with problem-solving tools (FMEA, DOE, SPC, etc.) and statistical techniques Expertise interfacing with R&D and manufacturing groups to optimize device design and processes Strong project management and cross-functional collaboration skills Experience working with contract manufacturers and supply chain partners Financial acumen with P&L responsibility experience Excellent communication skills with ability to present to board and investors Strong negotiation skills with internal and external stakeholders
of operations leadership experience in the medical device industry Previous VP of Operations role in a medical device startup (strongly preferred) Proven track record scaling manufacturing operations for Class II medical devices Experience with single-use disposable sterile medical device production Experience in startup or high-growth environments Experience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485 compliant quality systems Demonstrated success building MRP systems and supply chain operations from early stage Experience with direct-to-hospital sales and distribution models Required Skills & Abilities Deep knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards Proven ability to build and scale operations teams Thorough knowledge of materials and production scheduling systems, MRP, and cycle counting Experience working within FDA/ISO regulated environments Experience managing departmental budgets and P&L responsibility Experience complying with environmental health and safety regulations Demonstrated proficiency with problem-solving tools (FMEA, DOE, SPC, etc.) and statistical techniques Expertise interfacing with R&D and manufacturing groups to optimize device design and processes Strong project management and cross-functional collaboration skills Experience working with contract manufacturers and supply chain partners Financial acumen with P&L responsibility experience Excellent communication skills with ability to present to board and investors Strong negotiation skills with internal and external stakeholders