Senior Manager, Quality Systems

@ New World Medical, Inc.

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. We partner with eye care professionals to improve clinical outcomes and patient care. Our core values are Integrity, Accountability, and Innovation, and we support charitable initiatives to expand access to quality eye care.

Benefits starting Day One

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

Job Summary

The Senior Manager, Quality Systems is a strategic and operational leader responsible for overseeing, developing, and continuously improving New World Medical’s Quality Management System (QMS). The role ensures compliance with global regulatory standards while driving enterprise-wide quality initiatives. It requires collaboration with executive leadership to align quality strategies with business objectives, enhance readiness and foster a culture of compliance and innovation.

Essential Job Duties and Responsibilities

• Lead core QMS programs including full ownership of the CAPA system.
• Oversee Document Control systems for compliant document management.
• Maintain and enhance the Training Management System for regulatory alignment.
• Lead selection, validation, and implementation of QMS software solutions.
• Monitor regulatory standards (e.g., FDA QSR, ISO 13485) and update QMS accordingly.
• Advise executive leadership on quality system performance and risk mitigation.
• Drive audit readiness and lead both internal and external audits.
• Champion continuous improvement initiatives across the organization.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and IT for system integration.
• Direct root cause investigations and corrective actions to reduce quality issues.
• Provide leadership, coaching, and development to direct reports.
• Represent the Quality function in strategic planning and regulatory forums.
• Influence policy development, long-term planning, and organizational decision-making.

Requirements

• Expert understanding of quality system principles and global regulatory frameworks in the medical device industry.
• Proven leadership and team development skills with strong stakeholder engagement.
• Exceptional strategic thinking, organizational, and communication skills.
• Advanced analytical and problem-solving capabilities with data-driven decision-making.
• Experience with QMS software platforms, validation methodologies (e.g., GAMP 5, 21 CFR Part 11) and regulatory compliance.

Education and Experience

• Bachelor’s degree in scientific or engineering discipline required; Master’s preferred.
• Minimum 10 years in Quality Assurance or Regulatory Affairs, ideally in medical devices.
• At least 5 years in a leadership role managing quality systems and teams.
• Experience presenting to executive leadership and in strategic planning.
• Preferred certifications: ASQ (CQA, CQE), PMP, or equivalent.

Physical Requirements

The role requires remaining stationary for at least 50% of the time, occasional movement, operating office machinery, and the ability to lift up to 25 pounds.

Key skills/competency

• QMS
• CAPA
• Audit
• Document Control
• Training
• Regulatory Compliance
• Risk Mitigation
• Team Leadership
• Continuous Improvement
• Strategic Planning