Senior Quality Engineer (Hybrid)

Job Description

About this role :

iRhythm is currently seeking a Sr. Quality Engineer responsible for the coordination of product and process changes for Quality System Compliance activities, supporting equipment management, laboratory compliance and audit readiness at iRhythm Technologies. In this role, you will champion a quality culture mindset by driving company-wide operational excellence and quality awareness.

The Sr. Quality Engineer will report to the Manager, QMS Document Management and Training within the Quality Systems group. The role will work in close collaboration with Document Control, Training, Quality Control and Engineering Lab Manager. This position is based in San Francisco, CA, and is a full-time hybrid opportunity and will work in the office 3 days / week.

Specific job responsibilities include :

• Ensure iRhythm’s Quality System is compliant with internal procedures and applicable international standards / regulations
• Oversight of the change management process, including coordination of changes, review of changes, managing stakeholders and timely deliverables
• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations.
• Navigate through complex change review discussions, facilitating a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly
• Review and approve equipment calibration and preventive maintenance records
• Support nonconformance investigations and quarantine out of tolerance / damaged equipment
• Review and approve nonconformance dispositions and ensure that preventive and corrective measures are effective
• Perform and coordinate regular assessment of the engineering laboratory spaces
• Quarantine nonconforming material and ensure nonconformances are initiated
• Engage in continuous improvement activities by identifying opportunities and driving improvements to processes across the company.
• Receive, inspect, and process materials for formal verification and validation activities in the ERP
• Initiate and execute Quality Plans related to changes affecting the Quality System.
• Analyze business processes and responsibilities to identify opportunities for continuous improvement
• Provide guidance and support to project teams on change management principles, methodologies, and best practices.
• Foster a culture of continuous improvement and change readiness within the organization.
• Stay updated on industry trends and best practices in change management and apply them to enhance organizational change capabilities.
• Work with the eQMS team to implement changes for the process
• Provide support during inspections (FDA, Notified Body (ISO) and other regulatory agencies).
• Perform Internal Audits and assist in maintaining a constant state of inspection readiness at the San Francisco site.

About you :

What’s in it for you :

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short / long term disability.

Additionally, we offer :

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of LinkedIn Learning classes and so much more!

FLSA Status : Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. 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.

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

About iRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.