Quality Systems Engineer Lead

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

About This Role

The Quality Systems Engineer Lead is responsible for leading the implementation and continuous improvement of the Quality Management System, ensuring compliance and business strategy support across all regulated markets. The role maintains a compliant, data‑driven, and effective QMS and partners with Quality, Regulatory, Operations, Engineering, and Clinical teams to align with FDA 21 CFR Part 820, ISO 13485, EU MDR 2017 / 745, UK MDR 2002, and Japan MHLW / PMDA QMS Ordinance requirements.

What You Will Be Doing

• Lead projects related to improving the Quality System.
• Collaborate on implementation of strategies for quality improvement processes.
• Interpret and communicate trends; must have basic knowledge of statistical techniques.
• Be well‑versed with Quality System regulations.
• Work with stakeholders to identify improvement opportunities based on data insights.
• Define project deliverables by identifying detailed customer requirements, constraints, and assumptions.
• Drive identification, assessment, monitoring, and resolution of project risks.
• Manage QMS activities to support achievement of project milestones.
• Partner with key stakeholders to define actions and plans to develop a high‑performing, scalable, and compliant Quality System.
• Translate data and trends into actions to drive business decisions.
• Help identify product trends and drive actionable insights.
• Extract and format data from various systems per the respective processes.
• Develop and optimize methods to visualize data (Tableau dashboards, charts, presentations, etc.).
• Work with teams across all levels of the organization.
• Aid in coordination and support of e‑QMS upgrades, software tool upgrades, and improvement initiatives in relation to Quality System IT infrastructure.
• Lead and / or support investigation of complex quality issues.
• Lead workstream integration and remediation of Quality System policies and procedures as assigned.
• Conduct gap assessments and implement necessary process changes with subject‑matter experts.
• Engage in continuous improvement activities by identifying opportunities and recommending improvements across iRhythm.
• Other related duties as may be assigned.

What We Need to See

Location

San Francisco, CA – Must work on site 2‑3 times per week.

Estimated Pay Range

$141,450.00 – $184,000.00

Equal Opportunity Employer

iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

Reasonable Accommodations

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com .

#J-18808-Ljbffr