OrganOx · 19 hours ago
Senior Manager, QMS and Document Services
Madison, NJ, US
Full-time
Hybrid
Senior Level
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 Senior Manager, QMS & Document Services will oversee the architecture of the Quality Management System and document management processes, leading a global team to ensure compliance and operational excellence. This role requires collaboration across functions to embed a culture of quality and compliance within the organization.
Health CareMedicalMedical Device
Responsibilities
Build, lead, and develop a high-performing global QMS and Document Services team, with explicit accountability for long-term capability building, succession planning and leadership readiness across the function
Foster a culture of collaboration, accountability, and continuous learning, aligned with OrganOx’s values of Respect, Integrity, Care, Quality and Creativity while acting as a senior quality leader and role model across the organisation
Act as a visible and proactive quality leader across the business, owning the strategic direction of QMS and Document Services and engaging with senior stakeholders to align multi-year QMS strategy with company objectives, the product pipeline, geographic expansion, and OrganOx’s Quality Policy
Drive organisational capability in document services by developing best practices at enterprise level governance, training programs, and state-of-the-art knowledge-sharing across the business
Partner with leaders across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organisation
Act as delegated authority to Director, Quality Assurance, including leading during periods of absence and taking accountability for critical quality decisions
Lead the architecture, design, and continual improvement of the OrganOx QMS, with end to end strategic accountability for system effectiveness, scalability and regulatory readiness ensuring compliance with all applicable regulatory and quality standards
Provide strategic oversight and governance of document management, change control, and MasterControl-based processes, leading major system transformations, upgrades, and harmonisation initiatives to strengthen compliance and operational efficiency
Define and manage resource requirements, ensuring the team is equipped to deliver against business and compliance needs
Champion develops, define and roll-out relevant quality metrics, ensuring data-driven insights inform decisions, continuous improvement, and reporting to leadership
Lead the Document Services and QMS functions in Management Review, cross functional internal meetings, audits, and inspections, demonstrating leadership and developing organisational maturity
Be a role-model as a collaborative cross-functional partner, promoting consistent, high-quality practices across global sites
Lead team to provide timely and evidence-based communication to the Executive Team, peers, and global colleagues
Ensure effective budget management and resource allocation in collaboration with the Director, Quality Assurance and other stakeholders
Lead organisation-wide initiatives to build capability and engagement with quality systems, embedding compliance into daily operations
Proactively ensure compliance with all relevant international regulations, including US Code of Federal Regulations Title 21 (with emphasis on the pending QMSR), European Union MDR 2017/745, Canadian SOR 98-282, Australian TGA MDR 2002, and ISO 13485. Knowledge of Japanese PMDA requirements may be an advantage
Serve as a key contact point during internal and external audits, providing leadership presence and demonstrating system excellence
Continuously evaluate compliance risks, implementing robust mitigation and improvement strategies
Qualification
Required
A demonstrated record of success in Quality Management System oversight and development as demonstrated by successful regulatory audits and inspections
Must have at least 5 years experience of management of eQMS systems and either development, migration or remediation within an eQMS or other document control systems
Must have relevant knowledge of Product and Process Data Management with demonstrated success in design and implementation of eQMS or document control systems
An expert knowledge of Software-based Quality Management Systems
An expert-level knowledge of Document Control and Change Management
Demonstrated proficiency in leading and developing successful transaction-based teams
Demonstrated ability to lead organization-wide change initiatives and management
High level interpersonal skills to both lead a team and to influence the wider organization
A minimum of 5 years of experience in a regulated environment, preferably medical devices, is essential
Preferred
A degree in an engineering, science-related discipline is desirable or demonstrable experience
Knowledge of Japanese PMDA requirements may be an advantage
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