VP, Quality Systems

Job Summary

As a key member of the Quality and Regulatory leadership team, the Vice President, Quality Systems sets the vision for quality system strategy, fosters a culture of continuous improvement, and ensures alignment with corporate objectives and regulatory expectations. This leader develops the global quality systems roadmap, mitigates compliance risks, and partners cross-functionally to ensure the effective integration of quality systems into all business processes.

This role provides strategic leadership and oversight for all quality system activities, including but not limited to: corrective and preventive actions (CAPA), change control, document and record management, training, metrics and trending, non-conformance management, and post-market surveillance (PMS)-such as PMS Plans, PMS Reports, and Periodic Safety Update Reports (PSURs)-as well as responses to requests from regulatory authorities.

Duties & Responsibilities

Strategic Leadership

• Define and execute a comprehensive global quality strategy aligned with Masimo's innovation roadmap and international growth objectives.
• Establish annual goals and long-term plans for quality compliance functions, ensuring responsiveness to evolving global regulatory landscapes.
• Foster an organization-wide commitment to quality.

Regulatory Compliance & Risk Management

• Ensure compliance with global regulatory requirements, including but not limited to:
  FD&C Act Title 21, ISO 13485, ISO 14155, ISO 14971, EU MDR (Directive 2017/745), RED (Directive 2014/53/EU), RoHS (Directive 2011/65/EU), WEEE (Directive 2002/96/EC), Therapeutic Goods (Medical Devices) Regulations 2002 (Australia), Resolution RDC 665/2022 (Brazil GMP), Canada Medical Device Regulations (SOR-98/282), Japan Pharmaceutical and Medical Device Act (PMDA), Korean GMP, Swiss Medical Devices Ordinance (MedDO), UK Medical Device Regulations, and Saudi Arabia SFDA Medical Device Regulations.
• Lead risk-based decision-making across the product lifecycle-from development to post-market surveillance.
• Monitor and interpret changes in regulatory requirements and adjust internal strategies and systems accordingly.

Quality Compliance & Continuous Improvement

• Oversee the global QMS, ensuring compliance with applicable regulatory requirements and relevant standards.
• Drive continuous improvement initiatives across regulatory and quality functions to enhance operational excellence and product reliability.
• Support internal audits, regulatory inspections, FDA audits, and quality assurance across all global sites.

Leadership & Collaboration

• Build, mentor, and manage a high-performing global team of quality professionals.
• Collaborate cross-functionally with R&D, Operations, Clinical Affairs, Legal, and Marketing to integrate compliance early into product development.
• Act as a key contact with global regulatory authorities, managing agency interactions, audits, and inspection readiness.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 10+ years of progressive leadership experience in the medical device industry.
• Deep understanding of FDA, EU MDR, ISO 13485, MDSAP, and other global regulatory frameworks.
• Strong leadership, interpersonal, and communication skills, with the ability to work collaboratively across global and cross-functional teams.
• Experience in high-growth, innovation-driven environments and a strong passion for advancing patient-centric technologies.

Preferred Qualifications

• Lead Auditor (e.g., ISO13485) and Certified Quality Auditor (CQA) preferred

Education

Bachelor's degree in engineering, Life Sciences, or a related field required

Master's degree or quality/regulatory certification (e.g., RAC, CQA) preferred.

Compensation

The anticipated salary range for this position is $222,000 - $277,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 30% annual bonus based on Company, department, and individual performance.

Physical Requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.