Manager, Quality Management System (QMS) and Document Services

OrganOx • Madison, NJ

88d • $140,000 - $150,000

About The Position

The position of Manager QMS & Document Services is responsible for architecture of our Quality Management System and any and all infrastructure elements to affect an efficient and effective QMS and will further have responsibility to oversee, configure, continually improve our document management, change, and control processes. This role is critical to our ability to reflect our core values of customer first, be passionate, uphold respect and think boldly, and a commitment to transplantation. The Manager, QMS & Document Services will report directly to the Director, Quality Assurance. The Manager plays a key leadership role in building organizational capability leading, developing, and inspiring a global team; collaborating across functions; and embedding a culture of excellence in quality and compliance. Success in this role will be measured not only by the robustness of the QMS, but also by the strength, resilience, and effectiveness of the team delivering it.

Requirements

• Minimum of a bachelor’s degree in a Life Science, Engineering or Technical subject.
• A minimum of 4 years of document control and change management experience in the Medical Device, Pharmaceutical or other regulated industry.
• Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others.
• Strong knowledge of medical device standards and regulations such as US 21 CFR 820, EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485.
• Must have at least one year of experience managing direct report(s).
• Ability to travel internationally up to 10% annually.

Nice To Haves

• Experience in effective budget management and resource allocation.
• Knowledge of other relevant regulations and upcoming changes.

Responsibilities

• Build, lead, and develop a high-performing global QMS and Document Services team.
• Foster a culture of collaboration, accountability, and continuous learning.
• Act as a visible quality leader across the business, engaging with senior stakeholders.
• Drive organizational capability in document services by developing best practices.
• Partner with leaders across functions to embed QMS ownership and accountability.
• Lead the architecture, design, and continual improvement of the OrganOx QMS.
• Provide strategic oversight of document management, change control, and MasterControl-based processes.
• Define and manage resource requirements for the team.
• Champion the use of quality metrics for data-driven insights.
• Represent the Document Services and QMS functions in Management Review, audits, and inspections.
• Act as a collaborative cross-functional partner.
• Ensure effective budget management and resource allocation.
• Lead organization-wide initiatives to build capability and engagement with quality systems.
• Proactively ensure compliance with all relevant international regulations.
• Serve as a key contact point during internal and external audits.
• Continuously evaluate compliance risks and implement robust mitigation strategies.

Benefits

• Competitive compensation and comprehensive benefits available from day one.
• Health, dental, vision, and disability coverage.
• Flexible spending accounts.
• 401(k)-retirement plan with company matching after 90 days.
• Paid time off, holidays, and additional leave benefits.
• Employee discounts and access to onsite wellness facility.
• Opportunities for ongoing professional development.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees