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New World Medical · 7 hours ago

Senior Manager, Quality Systems (ONSITE)

Rancho Cucamonga, CA

Full-time

Onsite

Senior Level, Lead/Staff

$172K/yr - $196K/yr

10+ years exp

New World Medical is a mission-driven company focused on preserving and enhancing vision through innovative ophthalmic surgical devices. The Senior Manager, Quality Systems is responsible for the oversight, development, and continuous improvement of the Quality Management System, ensuring compliance with global regulatory standards while driving quality initiatives across the organization.

EyewearHealth CareMedical Device

Comp. & Benefits

Responsibilities

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

Qualification

Quality Management SystemRegulatory complianceQMS software implementationAnalytical skillsLeadership skillsStrategic thinkingStakeholder engagementTeam developmentCustomer interfaceDiscretionData-driven decision-makingCommunication skillsProblem-solvingIntegrity

Required

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 analytical and problem-solving capabilities with a focus on data-driven decision-making

High level of integrity and discretion in managing confidential and sensitive information

Effective stakeholder engagement and customer interface skills

Experience with QMS software platforms and validation methodologies (e.g., GAMP 5, 21 CFR Part 11 compliance)

Bachelor's degree in a scientific or engineering discipline required

Minimum of 10 years of experience in Quality Assurance or Regulatory Affairs within a regulated industry, preferably medical devices

Minimum of 5 years in a leadership role managing quality systems and teams

Demonstrated experience presenting to executive leadership and contributing to strategic planning

Experience leading QMS software implementation and validation projects

Must be able to remain in a stationary position at least 50% of the time

Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking

Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc

Ability to listen and speak with employees and vendors. Must be able to exchange accurate information in these situations

Occasionally lift up to 25 pounds and transport to other offices. This may be performed with reasonable accommodation

View and type on computer screens for long periods of time