Career-defining. Life-changing.

At iRhythm youll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone everywhere can access the best possible cardiac health solutions. Every day we collaborate create and constantly reimagine whats possible. We think big and move fast driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health our company and your career

About This Role :

Boldly innovating to create trusted solutions that detect predict and prevent disease.

Discover your power to innovate while making a difference in patients lives. iRhythm is advancing cardiac careJoin Us Now!

At iRhythm we are dedicated self-motivated and driven to do the right thing for our patients clinicians and coworkers. Our leadership is focused and committed to iRhythms employees and the mission of the company. We are better together embrace change and help one another. We are Thinking Bigger and

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 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 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 iRhythms 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 :

Bachelors Degree or equivalent quality / regulatory experience with medical devices.

Minimum of 5 years of experience in a Quality Assurance in the Medical Device Industry.

Must have a deep understanding of medical device Quality Management Systems and associated regulatory requirements.

Experience in coordination and controlling equipment calibration and Preventive Maintenance.

Ability to adapt to a fast-paced and evolving environment.

Previous experience in a medical device manufacturing setting with working knowledge of ISOCFR 820 and ISO 14971

Ability to read and comprehend drawings diagrams and work instructions.

Experience with various hand tools like micrometer height gauge drop gauges etc.

Strong understanding of GD&T.

Will need to demonstrate the ability to manage multiple changes of varying complexity and scope of tasks in a fast-paced environment to meet timelines.

Demonstrates Project Management abilities to lead and manage several projects meet deadlines and use critical thinking skills to solve problems effectively.

Demonstrates strong interpersonal skills with ability to influence negotiate manage conflict and negotiate.

Demonstrates excellent verbal and written communication skills to all levels of the organization. Technical writing skills required.

Strong investigation and problem-solving skills

Must build rapport across functional teams within the organization.

Attention to detail and timeliness are critical.

Ability to work independently with flexibility and organizational awareness.

Whats 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 :

emotional health support for you and your loved ones

legal / financial / identity theft / pet and child referral assistance

paid parental leave paid holidays travel assistance for personal trips and PTO!

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

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 iRhythms 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.

Location : San Francisco

Actual compensation may vary depending on job-related factors including knowledge skills experience and work location.

Estimated Pay Range

115200.00 - $150000.00

As a part of our core values we ensure an 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 accommodations 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

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 iRhythms 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.

Required Experience :

Senior IC

Key Skills

Quality Assurance,Six Sigma,Design Controls,FDA Regulations,ISO 9001,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 115200 - 150000