Senior Manager, Quality Systems; ONSITE

About New World Medical

Founded in 1990, New World Medical is a mission-driven company focused on preserving and enhancing vision through innovative ophthalmic surgical devices, including the Ahmed Glaucoma Valve and Kahook Dual Blade. We partner closely with eye care professionals to deliver tools that improve clinical outcomes and patient care. Guided by our core values — Gratitude, Collaboration, and Impact, we strive to make a meaningful impact in eye health worldwide.

In support of our global mission, we proudly donate surgical equipment to charitable organizations to expand access to quality eye care.

• Medical, Dental, and Vision Insurance
• 401(k) with Profit Share
• Bonus Opportunities
• Flexible Work Schedules
• Free Onsite Daily Lunches to foster team connection
• Career Development Program
• Tuition Assistance (after 1 year of service)
• Cell Phone & Home Office Stipends
• Wellness & Employee Assistance Programs
• Company Events & Recognition
• And more!

The Senior Manager, Quality Systems is a strategic and operational leader responsible for the oversight, development, and continuous improvement of New World Medical’s Quality Management System (QMS). This role ensures compliance with global regulatory standards while driving enterprise-wide quality initiatives. As a key member of the QA/RA leadership team, the Senior Manager collaborates with executive leadership to align quality strategies with business objectives, enhance organizational readiness, and foster a culture of compliance, accountability, and innovation.

The role also serves as a visible champion for quality excellence across the organization, influencing long‑term planning, policy development, and digital transformation of quality systems.

• Lead and manage core QMS programs
  , including full ownership of the Corrective and Preventive Action (CAPA) system, ensuring timely investigation, resolution, and closure of quality issues.
• Oversee the Document Control system
  , ensuring accurate, compliant, and efficient management of controlled documents, records, and change control processes.
• Maintain and enhance the Training Management System
  , ensuring training compliance across departments and alignment with regulatory and procedural requirements.
• Lead the selection, validation, and implementation of QMS software solutions
  , ensuring systems meet business needs, regulatory requirements, and scalability goals.
• Monitor and interpret evolving regulatory standards and industry guidelines (e.g., FDA QSR, ISO 13485, ISO 14971, MDR), and proactively implement updates to the QMS to ensure continued compliance.
• Serve as a key advisor to executive leadership on quality system performance, risk mitigation strategies, and regulatory trends.
• Drive audit readiness and lead internal and external audits, contributing to successful inspections with zero major findings.
• Champion enterprise-wide continuous improvement initiatives that enhance system efficiency, reduce CAPA cycle time, and improve training completion rates.
• Lead cross-functional collaboration with Manufacturing, R&D, Regulatory Affairs, and IT to ensure quality system integration, scalability, and sustainability.
• Direct and support root cause investigations and corrective/preventive actions, achieving measurable reductions in recurring quality issues.
• Provide leadership, coaching, and development to direct reports, improving team engagement, capability, and performance outcomes.
• Represent the Quality function in strategic planning sessions, regulatory inspections, and executive-level forums.
• Influence policy development, long‑term quality planning, and organizational decision‑making to support business growth and regulatory compliance.

• Expert‑level understanding of quality system principles and global regulatory frameworks in the medical device industry.
• Proven ability to lead and develop high‑performing teams and influence cross‑functional and executive stakeholders.
• Strong strategic thinking, organizational, and communication skills.
• Advanced…