Sr Director, Quality

Job Summary:

The Senior Director, Quality provides strategic leadership in shaping and advancing Masimo's global quality roadmap to support innovation, regulatory compliance, global market access, and long-term business objectives. This role partners closely with executive leadership and cross-functional stakeholders across R&D, Operations, Clinical, and Commercial organizations to strengthen quality systems, anticipate regulatory trends, mitigate enterprise risk, and ensure continued alignment of quality strategies with evolving business needs.

This leader is responsible for driving initiatives that ensure product quality, patient safety, and global compliance while enabling operational efficiency and speed to market. The role requires balancing strong compliance oversight with a proactive approach to continuous improvement, helping position Masimo for sustained success as a global leader in healthcare technology.

Duties & Responsibilities:

• Define and execute Masimo's global quality strategy in alignment with enterprise priorities, growth objectives, and evolving regulatory expectations.
• Assess quality risks across global sites and operations, identifying opportunities to strengthen compliance, improve processes, and mitigate enterprise risk.
• Monitor emerging global regulatory and quality trends, evaluating business impact and recommending strategic actions to support market access and product lifecycle needs.
• Serve as a strategic advisor to the EVP, Quality & Regulatory and senior leadership on complex quality, compliance, and risk-related matters.
• Establish annual objectives and long-range plans that strengthen organizational readiness and responsiveness across global quality operations.
• Ensure compliance with applicable global quality and regulatory requirements, including FDA Quality System Regulation, ISO 13485, ISO 14971, EU MDR, MDSAP, and other international medical device regulations.
• Partner with Quality, Regulatory Affairs, Operations, and cross-functional teams to execute compliance strategies across global sites and product portfolios.
• Drive continuous enhancement of quality systems, processes, and performance metrics to support evolving regulatory standards and business requirements.
• Lead development and execution of the corporate quality audit strategy to proactively identify compliance risks and strengthen quality maturity across the organization.
• Support internal audits, regulatory inspections, FDA inspections, and quality assessments across domestic and international operations.
• Drive cross-functional corrective actions and continuous improvement initiatives resulting from audit findings, inspection observations, and internal assessments.
• Provide leadership for field action processes, ensuring timely, compliant, and effective execution of recalls, corrections, removals, and customer notifications.
• Partner with global sites, internal teams, and customers to ensure field action accountability, product reconciliation, and documentation compliance.
• Support development and management of field action strategies, customer communications, status reporting, and closure activities.
• Build, develop, and lead a high-performing quality organization capable of supporting enterprise growth and global complexity.
• Collaborate cross-functionally with R&D, Operations, Clinical Affairs, Regulatory Affairs, Legal, and Commercial teams to integrate quality principles throughout the product lifecycle.
• Lead strategic quality initiatives that strengthen compliance, operational effectiveness, and business performance.
• Ability to read, write, and communicate effectively in English.
• Ability to interpret technical documents, schematics, and written instructions.
• Ability to clearly document technical findings and communicate with cross-functional team members.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline required.
• 10+ years of progressive leadership experience within the medical device industry, including significant quality leadership responsibility.
• Deep knowledge of global medical device quality systems and regulatory requirements, including FDA, ISO 13485, EU MDR, and related international frameworks.
• Demonstrated ability to lead through complexity and influence senior leaders across global, cross-functional organizations.
• Strong strategic thinking, problem-solving, and communication skills with the ability to balance compliance requirements and business priorities.

Preferred Qualifications:

• Master's degree in Engineering, Life Sciences, Business, or related field preferred.
• Quality or regulatory certification such as RAC, CQA, or equivalent preferred.
• Experience leading enterprise quality initiatives in a high-growth, innovation-driven medical device environment.
• Familiarity with software-enabled medical technologies, digital health, or software as a medical device (SaMD).
• Experience engaging directly with regulatory agencies, notified bodies, and external industry organizations.

Education:

Bachelor's degree in Engineering, Life Sciences, or related technical discipline required; Master's degree or advanced certification in Quality, Regulatory Affairs, or a related field preferred.

Compensation:

The anticipated salary range for this position is $208K - $260K 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 25% 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 Clinic, Fitness Center, and Cafe. All benefits are subject to eligibility requirements.

Language requirements

• Ability to read, write, and communicate effectively in English.
• Ability to interpret technical documents, schematics, and written instructions.
• Ability to clearly document technical findings and communicate with cross-functional team

Physical requirements/Work Environment

This position primarily works in a laboratory 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.

Masimo is an Equal Employment Opportunity Commission / Affirmative Action Employer. We encourage Minorities, Females, Disabled and Veterans to apply.