Director, Quality Customer Complaints

Masimo•Irvine, CA

2d•$160,000 - $210,000

About The Position

The Director, Quality Customer Complaints provides strategic leadership and oversight of Masimo’s global complaint handling process. This role is responsible for ensuring timely, consistent and accurate processing of customer complaints; driving cross-functional investigations; and improving organizational performance in complaint management. The Director leads a team and partners closely with internal and external stakeholders, and represents the function during internal audits, external inspections, and regulatory engagements. This position plays a critical role in shaping complaint strategy, identifying systemic risks and trends, and driving continuous improvement across Masimo’s post-market surveillance system.

Requirements

8–10+ years of complaint handling, post-market surveillance, or quality systems experience in the medical device industry.
5+ years of progressive leadership experience managing teams and/or managers.
Prior experience with MedWatch and international reporting requirements.
Expertise in FDA Quality System Regulations (21 CFR 820 and 803), EU MDR, MDD, MEDDEV guidance, ISO 13485, and related quality standards.
Strong computer, analytical, and organizational skills.
Demonstrated leadership and communication skills with strong attention to detail.
Ability to multitask in a fast-paced environment and manage shifting priorities.
Ability to interact effectively across teams and with internal/external stakeholders.
Bachelor’s Degree required, preferably within the Sciences, Engineering, or Clinical fields.
Must be proficient in English. Can understand with ease virtually everything heard or read. Can summarize information from different spoken and written sources, reconstructing arguments and accounts in a coherent presentation. Can express him/herself spontaneously, very fluently and precisely, differentiating finer shades of meaning even in more complex situations.

Nice To Haves

Clinical background or clinical risk-management experience.
Lean Six Sigma Black Belt or Green Belt certification.
Experience leading global teams or partnering with OEMs.
Advanced degree in a scientific or related discipline preferred.

Responsibilities

Provide strategic direction for the global complaint handling program to ensure compliance with FDA QSR, EU MDR, international regulations, ISO 13485, and internal quality standards.
Oversee the end-to-end complaint lifecycle, including intake, documentation, investigation, root-cause analysis, regulatory assessment, closure, and customer response.
Ensure timely and exact completion of complaint investigations, coordinating with Engineering, Clinical, Failure Analysis, Operations, Technical Service, and other partners.
Lead escalation of significant complaints, emerging failure modes, systemic product issues, and potential product related risks.
Represent the complaint handling function during internal audits, notified body assessments, and regulatory inspections.
Develop, monitor, and report key complaint metrics, trends, and systemic insights to senior leadership; drive corrective and preventive actions, where required.
Provide oversight in drafting, reviewing, and approving customer communication, MedWatch reports, and other international reporting documentation.
Collaborate with the Clinical team on patient-risk assessments and safety evaluation of adverse events.
Partner with field personnel, hospitals, physicians, and risk-management contacts during adverse event investigations.
Lead, develop, and coach a team including a manager, and specialists; oversee hiring, promotions, workload planning, performance management, and career development.
Improve complaint handling capability by establishing clear expectations, training pathways, and operational improvements.
Perform other duties and special projects, as assigned.