Senior Quality Systems Leader — Audit & Compliance

Boston Scientific; Santa Clarita (CA); On-site; USD 132,000 - 250,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Systems Manager in Santa Clarita, CA to lead the quality organization and ensure ISO 13485 and FDA QMSR compliance, maintaining inspection readiness.

You will mentor a team of quality professionals, drive CAPA, internal audits, document control, and QMS improvements while partnering across the global network to sustain a culture of prevention and continuous improvement.

Qualifications

• Bachelor’s degree in engineering, science, or a related technical discipline.
• Minimum of seven years of demonstrated quality management experience.
• Minimum of three years of direct people leadership experience.
• Strong knowledge of Medical Device regulations, specifically ISO 13485 and FDA QMSR.
• Ability to influence and collaborate effectively in a high-performing, matrixed global organization.
• Leadership experience with FDA inspections and international regulatory or notified body audits.

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
• Translation of 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 leadership

Regulatory knowledge

Leadership

Problem-solving

Stakeholder influence

Education

Bachelor’s degree in engineering, science, or a related technical discipline

Job description

Boston Scientific is seeking a Senior Quality Systems Manager in Santa Clarita, CA to lead the quality organization and ensure ISO 13485 and FDA QMSR compliance, maintaining inspection readiness.

You will mentor a team of quality professionals, drive CAPA, internal audits, document control, and QMS improvements while partnering across the global network to sustain a culture of prevention and continuous improvement.