OrganOx · 23 hours ago
Outsourcing Operations Leader
United States
Full-time
Remote
Senior Level
$110K/yr - $125K/yr
5+ years expOrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The Outsourcing Operations Leader will manage and develop the relationship with a US-based CDMO for the manufacture and continuity of supply of the OrganOx metra® system.
Health CareMedicalMedical Device
Responsibilities
Act as the primary point of contact for all CDMO-related activities and issues within the United States
Develop and maintain effective relationships with local US suppliers to foster collaboration and trust
Be responsible for strategy input and execution for suppliers supporting the American market only
Deliver key category performance indicators, including savings, risk mitigation, and quality assurance within the US supply base
Supplier selection, onboarding, lifecycle management, and potential management of phase-out specific to the US market, rationalise supplier base
Reorganize supply chain
Redefine supplier strategy
Collaborates with suppliers, regulatory and quality team to implement and monitor quality assurance protocols specific to medical devices, ensuring adherence to industry best practices and regulatory requirements
Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies
End to end supply chain management of key suppliers including business reviews to manage KPI's
Develop and deploy structured Category Management processes and define supplier management strategies
Assesses impact and refines category plans to support business requirements
Document processes and procedures related to supplier development
Engages and supports procurement and quality teams to qualify key suppliers & migrate spend from incumbent, poor performance suppliers
Develop and deploy supplier performance metrics, to drive continuous improvement and ensure continuity of supply, analyses category supplier performance data to find opportunities for supplier performance improvement establishing continuous improvement goals and deploying adequate projects or activities
Aligned with the category strategy, collaborate with the Procurement to negotiate supply agreements
Coordinate Supplier Change control to ensure that any changes in the supply chain do not compromise the quality or compliance of medical devices
Manage the OrganOx cross function team to ensure all activities and projects are executed and prioritized to maintain supply continuity
Coordinates with regulatory affairs to ensure all supplier-related documentation meets the necessary regulatory requirements for medical devices
Influences cross-functional colleagues (quality, engineering, operations, finance, etc.) to ensure category strategies and activities are aligned with key driver goals, business priorities and financial imperatives
Works with supplier and leads cross-functional internal teams to advance key business drivers such as supply continuity, quality, cost and operational performance
Develop supplier strategic partnerships and secures capacity with suppliers (asset management, unconstraint capacity...)
Collaborates with cross-functional colleagues to enable and support suppliers' performance
Enable team to develop predictive analytics
Acts as a coach/mentor to colleagues on category strategy process
Based on business requirements, forecast the category team resources allocation, and animate hiring process
Drive stakeholder response to expedite key supplier issues, and drive resolution
Qualification
Required
5+ years of experience in supply chain management, supplier development, procurement, or manufacturing within regulated industry required
Proven experience in establishing and managing supplier agreements, contracts, and logistics arrangements
Experience in supplier risk management, escalation handling, and performance tracking required
Strong problem-solving mindset with a proactive approach to supply chain continuity required
Good communication skills, including strong written, verbal and data summation abilities
Bachelor's degree or equivalent in a supply chain, operations, manufacturing or related field required
Preferred
Wisconsin preferred
Strong understanding of medical device manufacturing standards (GMP, ISO 13485, 21 CFR 820, EU MDR) preferred
Ability to lead cross-functional teams and drive collaboration between Procurement, Supply Chain, and Quality preferred
Master's degree preferred
Lean or Six Sigma process improvement qualifications preferred
Benefits
Health, dental, vision, disability coverage, and flexible spending accounts
401(k)-retirement plan with company matching after 90 days
Paid time off
Holidays
Additional leave benefits
Employee discounts
Access to our onsite wellness facility
Opportunities for ongoing professional development
Company
OrganOx
OrganOx is a medical technology company.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$206.97MKey Investors
HealthQuest CapitalLauxera Capital PartnersBusiness Growth Fund
2025-08-23Acquired
2025-02-24Series Unknown· $160M
2025-02-24Secondary Market
Leadership Team
Steve Deitsch
CFO
Recent News
Medical Device Network
2026-01-07
2025-12-10
Company data provided by crunchbase