Quality Systems Engineer Lead

Career-defining. Life-changing.

At iRhythm, you'll 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 what's 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:

The Quality Systems Engineer Lead is responsible for leading the implementation and continuous improvement of the Quality Management System, ensuring that Quality System processes effectively support compliance and business strategy across all regulated markets. This position helps to ensure the organization maintains a compliant, data-driven, and effective Quality Management System (QMS). The individual will serve as a subject matter expert (SME) within the QMS and will partner cross-functionally with Quality, Regulatory, Operations, Engineering and Clinical teams to ensure alignment 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 that are related to improving the Quality System
• Collaborate on the implementation of strategies for Quality improvement processes
• Interpret and communicate trends, must have basic knowledge of statistical techniques
• Must be well-versed with Quality System Regulations
• Work with stakeholders and other business leaders to identify opportunities for improvement based on data insights
• Identify detailed customer requirements, constraints, and assumptions with stakeholders to establish project deliverables.
• Drive the identification, assessment, monitoring, and resolution of project risks.
• Manage QMS activities to support the achievement of project milestones.
• Partners with key stakeholders to define actions and plans to develop and maintain 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 together 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 of the 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.
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to processes across iRhythm.
• Other related duties as may be assigned.

What We Need to See

• Bachelor's Degreeor equivalent experience.
• Minimum of8years ofexperience in a Quality or Regulatory role, preferably in medical devices with at least 6 years of experience working in the Quality System.
• Direct experience in Quality System processes and project management.
• Strong leadership presence with excellent communication (verbal and written) and interpersonal skills required
• Experience managing team projects, including experience as an active contributor on projects with scheduled deliverables.
• Ability to manage complexity, analytical, and resource management on a global basis.
• Strong working knowledge of GxPs, ISO 13485 and 14971 and FDA and EU MDR regulations
• Strong analytical skills with demonstrated ability to troubleshoot complex process issues.
• Attention to detail and timeliness are critical.
• Able to provide quality service cross-functionally
• Ability and willingness to coach, mentor, and train employees
• Must operate through collaboration and transparency.
• Must be a positive and energeticleaderwho is motivated to develop and grow a teamwith integrity.

Location - Must be able to work on site 2-3 times per week (SF site)

Location:

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

Estimated Pay Range

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 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.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121