Vice President, Quality

The Vice President of Quality – OEM provides strategic direction and leadership for all Quality activities related to Masimo's OEM business. This includes oversight of product quality, regulatory compliance, supplier quality, and inspection functions across the OEM portfolio. The role ensures that OEM products and partnerships meet Masimo's high standards of safety, reliability, and compliance with applicable global regulations. The Vice President partners with internal stakeholders and external OEM partners to build scalable quality systems that balance business needs with regulatory requirements. This role advises senior management on OEM quality issues and leads the successful execution of OEM-related quality projects in collaboration with cross-functional groups.

Duties & Responsibilities:

• Provide strategic leadership and governance for all Quality Assurance activities supporting OEM products and partnerships.
• Ensure the OEM Quality Management System (QMS) is implemented, maintained, and continually improved.
• Develop and execute quality strategies to ensure OEM compliance with global regulatory requirements (FDA QSR, ISO 13485, EU MDR, CMDR, and equivalent).
• Lead quality planning, audits, and supplier assessments for OEM products.
• Oversee quality aspects of OEM product development, transfer, and lifecycle management.
• Collaborate with OEM partners to align on quality requirements, specifications, and issue resolution.
• Monitor and analyze OEM product performance and field data, identifying opportunities for improved reliability and reduced defects.
• Direct root cause analysis, CAPA, and risk management processes related to OEM quality issues.
• Ensure timely and effective communication of OEM quality performance and risks to senior leadership.
• Represent Masimo Quality in OEM partner meetings and negotiations.
• Lead special projects or initiatives as requested by senior leadership.

Minimum Qualifications:

• Fifteen or more years of experience in Quality Assurance, with at least 7 years in leadership roles in medical devices or OEM environments.
• Deep knowledge of Quality System Regulation (QSR), ISO-13485, EU MDR, CMDR, and global regulatory requirements.
• Proven ability to manage OEM or supplier quality functions and relationships.
• Strong communication, negotiation, and partnership skills with both internal stakeholders and external OEM partners.
• Demonstrated experience leading quality in a complex, global, regulated environment.

Preferred Qualifications:

• Master's degree in Engineering, Quality, or a related technical discipline.
• Experience with global OEM supply chain and multi-region regulatory compliance.

Education:

Bachelor's degree in a technical discipline required; advanced degree preferred.

Compensation:

The anticipated salary range for this position is $220k-$270K 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.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site wellness center, Fitness Center, and Cafe. All benefits are subject to eligibility requirements.

Physical Requirements / Work Environment:

This position primarily works in an office environment with frequent sitting, standing, and walking. Regular computer use is required. Occasional domestic and international travel may be necessary to support OEM supplier and partner quality oversight.