Global Quality Systems Lead — Medical Device

Boston Scientific Gruppe; California (MO); On-site; USD 132,000 - 250,000; Full time

Job summary

Boston Scientific in the Los Angeles area seeks a Senior Quality Systems Manager to lead global quality programs, ensuring ISO 13485 and FDA QMSR compliance while driving continuous improvement across the site and network.

The role heads a team of quality professionals, manages internal audits, CAPA, and document control, and ensures inspection readiness and metrology oversight. A focus on prevention and collaboration supports high-quality patient care.

Qualifications

• Bachelor’s degree in engineering, science, or related technical discipline.
• Minimum of seven years of quality management experience.
• Minimum of three years of direct people leadership experience.
• Strong knowledge of ISO 13485 and FDA QMSR.
• Experience with FDA inspections and international audits.
• Strong analytical and problem-solving skills.
• Ability to influence and collaborate effectively in a global matrix organization.

Responsibilities

• Lead, coach, and develop quality professionals; establish clear priorities, allocate resources, support individual development, and maintain a high-performing team.
• Provide strong leadership for management of the division’s internal audit program, CAPA system, document control activities, and Quality Management Review process
• Analyze quality data for trends, emerging risks, recurring issues, and opportunities for improvement; drive actions resulting from management review through completion and effectiveness evaluation
• Translate external regulatory requirements, standards, and emerging expectations into practical and sustainable quality system processes by working closely with the global quality organization
• Serve as Quality leader for management of divisional inspection readiness and lead execution of External Regulatory inspections and audit
• Serve as Quality Manager for the metrology laboratory day-to-day management in support of business objectives and quality objectives
• Apply professional expertise when making risk-based decisions to recommend compliant solutions, proactively resolve issues, and evaluate potential quality and business impacts
• Lead and deliver quality continuous improvement projects that support divisional and functional objectives and improve overall Quality System effectiveness and efficiency
• Build strategic partnerships across the division and global Boston Scientific network to provide strategic guidance to achieve organizational and Quality System goals
• Represent the division and quality function at site and cross-site meetings and global quality system communities of practice
• Keep Boston Scientific’s mission, values, and behaviors at the forefront of decisions and actions
• Champion a culture of prevention, compliance, and continuous improvement across the team, function, and site while demonstrating effective leadership through change
• Foster a diverse and inclusive workplace where all employees can contribute to their full potential in pursuit of organizational objectives

Skills

Quality management

People leadership

Regulatory knowledge

Data analysis

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in engineering/science

Tools

Audit facilitation

CAPA system

Document control

Quality Management System

Job description

Boston Scientific in the Los Angeles area seeks a Senior Quality Systems Manager to lead global quality programs, ensuring ISO 13485 and FDA QMSR compliance while driving continuous improvement across the site and network.

The role heads a team of quality professionals, manages internal audits, CAPA, and document control, and ensures inspection readiness and metrology oversight. A focus on prevention and collaboration supports high-quality patient care.