Vice President, Quality OEM & NPD

The Vice President of Quality - OEM & NPD provides strategic leadership and oversight of all Quality activities supporting Masimo's Original Equipment Manufacturer (OEM) business and New Product Development (NPD) initiatives. This role ensures the seamless integration of quality systems, design assurance, and compliance practices throughout the product lifecycle-from concept through commercialization-while upholding Masimo's uncompromising standards of safety, reliability, and regulatory compliance.

The Vice President partners closely with internal R&D, Regulatory Affairs, Operations, and Manufacturing leaders, as well as external OEM partners, to develop scalable, proactive, and innovative quality solutions that enable both business growth and compliance excellence. This role serves as a senior advisor to executive leadership on quality strategy, risk management, and global regulatory alignment for OEM and NPD programs.

Duties & Responsibilities:

• Provide strategic leadership and governance for all Quality Assurance and Design Quality activities supporting OEM products and NPD programs.
• Ensure the Quality Management System (QMS) is effectively implemented, maintained, and continuously improved across both OEM and NPD functions.
• Partner with R&D and Engineering teams to integrate quality and regulatory requirements into product design, verification/validation, and transfer activities.
• Lead quality planning and risk management throughout the NPD lifecycle, ensuring robust design controls and compliance with applicable global regulations (FDA QSR, ISO 13485, EU MDR, CMDR, etc.).
• Oversee supplier and component qualification, process validation, and production readiness for new and existing products.
• Collaborate with OEM partners and internal stakeholders to establish and maintain quality agreements, performance metrics, and escalation protocols.
• Drive issue resolution, CAPA, and continuous improvement initiatives related to product quality and field performance.
• Monitor and analyze product reliability, complaint trends, and post-market surveillance data to identify opportunities for improvement and innovation.
• Provide executive-level reporting on OEM and NPD quality performance, metrics, and risk assessments to senior leadership.
• Represent Masimo Quality in executive reviews, audits, regulatory inspections, and OEM partner negotiations.
• Foster a culture of quality, collaboration, and accountability within cross-functional global teams.
• Lead special projects and strategic initiatives to enhance organizational capability and regulatory readiness.

Minimum Qualifications:

• Fifteen or more years of progressive experience in Quality Assurance, with at least seven years in senior leadership roles within the medical device industry.
• Proven expertise leading Quality for both OEM and New Product Development programs.
• Deep knowledge of global medical device quality and regulatory frameworks (FDA QSR, ISO 13485, EU MDR, CMDR, etc.).
• Demonstrated success building and leading teams that partner effectively across R&D, Regulatory, Operations, and external partnerships.
• Exceptional communication, influence, and negotiation skills with both internal and external stakeholders.
• Track record of driving strategic quality initiatives in complex, global, and regulated environments.

Preferred Qualifications:

• Master's degree in Engineering, Quality, or a related technical discipline.
• Experience in global OEM and NPD environments with multi-region regulatory oversight.
• Prior experience leading Design Assurance and/or Development Quality Engineering functions.

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.