Sr Director, Quality

Masimo•Irvine, CA

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.