Director of Compliance and Quality

Tombot•Santa Clarita, CA

10h•$155,000 - $175,000•Onsite

About The Position

Tombot is a robotics startup company based in the greater Los Angeles area. Jennie, our robotic puppy, was named a Best of CES® Award winner at CES 2026, and was designed to support over 50 million seniors with dementia worldwide. We’re building a passionate team to help deliver these life-changing robotic companions to the people who need them most. Tombot is seeking a Director of Compliance and Quality to build, lead, and scale the company’s quality and regulatory compliance function as the business grows and prepares for future FDA-regulated product requirements. This role will be responsible for building Tombot’s quality foundation from the ground up, including developing and owning the Quality Manual, Quality Management System, CAPA processes, supplier quality program, product certification processes, and quality-related post-sales processes. The Director will help ensure Tombot’s products, vendors, manufacturers, documentation, and internal processes meet applicable quality and regulatory requirements. This is a hands-on leadership role for someone who has built quality systems before, understands FDA Class II medical device expectations, and knows how to create practical, scalable processes in a startup environment. The ideal candidate has experience working with overseas manufacturers, especially in Asia, and can partner effectively across Engineering, Manufacturing, Operations, Customer Support, Product Repair, and leadership. This role is highly cross-functional and will serve as a key owner of quality data, product failure trends, supplier performance, CAPA activity, audits, regulatory readiness, and continuous improvement. The right person will be quality and process focused, data driven, action oriented, and committed to building systems that improve product reliability, customer experience, and company execution.

Requirements

Bachelor’s degree in Engineering, Quality, Regulatory Affairs, Life Sciences, Manufacturing, Operations, or a related field.
8+ years of experience in quality, compliance, quality assurance, regulatory affairs, supplier quality, manufacturing quality, or a related function.
3+ years of experience leading quality programs, quality teams, supplier quality functions, or quality system implementation.
Experience with FDA Class II medical devices and applicable FDA quality system requirements.
Experience creating Quality Manuals and building, owning, or scaling a Quality Management System.
Experience setting up and managing CAPA processes, complaint handling, post-sales service quality processes, or product failure analysis processes.
Experience working with overseas manufacturers, contract manufacturers, or supplier networks, preferably in Asia.
Experience managing supplier qualification, supplier audits, supplier scorecards, performance metrics, corrective actions, and ongoing vendor quality.
Experience partnering cross-functionally with Engineering, Manufacturing, Operations, Customer Support, Product Repair, and executive leadership.
Strong quality systems expertise, with the ability to build practical, scalable quality processes, documentation, controls, and operating rhythms from the ground up.
Strong knowledge of FDA Class II medical device quality expectations, QMSR, ISO 13485, CAPA, supplier quality, complaint handling, and audit readiness.
Strong supplier quality and manufacturing quality judgment, including the ability to assess vendors, audit manufacturers, identify quality risks, and drive corrective actions.
Strong analytical skills, with the ability to use quality data, RMA trends, CAPA data, supplier metrics, product failure data, and customer feedback to identify root causes and improvement opportunities.
Strong cross-functional leadership skills, with the ability to partner with Engineering, Manufacturing, Operations, Customer Support, Product Repair, suppliers, and leadership to resolve quality issues.
Strong documentation and process discipline, including the ability to create clear procedures, quality records, audit documentation, scorecards, reports, and compliance-ready materials.
Ability to operate effectively in a startup environment where systems are still being built and leaders are expected to be both strategic and hands-on.
Action-oriented, detail-oriented, and committed to continuous improvement, product reliability, process control, and customer safety.
Ability to remain stationary for extended periods of time
Ability to lift up to 40 pounds
Ability to operate standard office equipment
Applicants must be authorized to work in the United States. Tombot does not currently provide employment visa sponsorship.
Tombot participates in E-Verify to confirm work authorization.

Nice To Haves

Experience in robotics, medical devices, health technology, consumer electronics, hardware, IoT devices, or other complex electromechanical products.
Experience with ISO 13485 implementation, FDA inspections, external audits, internal audits, supplier audits, or management review processes.
Experience supporting FDA registration, regulatory submissions, device listings, product certifications, product testing, or regulatory documentation.
Experience building quality systems in a startup, early-stage, or high-growth company.
Experience managing international quality team members, overseas suppliers, contract manufacturers, or manufacturing partners in Asia.
Experience creating dashboards, supplier scorecards, CAPA reports, RMA quality reports, product failure trend reports, or executive quality reporting.
Experience with quality management software, ERP systems, document control tools, PLM systems, ticketing systems, or other systems used to manage quality records and compliance activity.

Responsibilities

Build and own Tombot’s Quality Management System, Quality Manual, quality guidelines, policies, procedures, documentation standards, and operating rhythms.
Develop, implement, and manage CAPA processes, including issue identification, root cause analysis, corrective actions, preventive actions, effectiveness checks, and ongoing reporting.
Support FDA registration, regulatory submissions, product certifications, testing requirements, and ongoing compliance with applicable FDA and medical device quality requirements.
Monitor changing regulatory requirements and ensure internal processes, documentation, vendors, and manufacturers remain aligned with applicable standards and expectations.
Build and manage the supplier quality program, including supplier qualification, audits, scorecards, performance metrics, corrective actions, and ongoing quality reviews.
Oversee the quality of vendors, contract manufacturers, and overseas manufacturing partners, with a focus on process control, product quality, documentation, and continuous improvement.
Own the quality aspects of the RMA process, including return analysis procedures, failure categorization, root cause trends, product failure monitoring, and quality feedback loops.
Collaborate with Engineering, Manufacturing, Operations, Customer Support, Product Repair, and leadership to analyze quality data, resolve recurring issues, improve processes, and improve product reliability.
Oversee international quality team members, vendors, consultants, or partners as the quality function scales.
Lead internal and external audit readiness, support manufacturer audits, and ensure quality records are complete, accurate, and inspection-ready.