Sr. Manager Management Controls

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:

In this role you will be responsible for leading the design implementation and continuous improvement of the company’s global management control framework ensuring that Quality System processes effectively support compliance and business strategy across all regulated markets

You will oversee Management Review Quality Planning Quality Objectives and the electronic Quality Management System (eQMS) 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) for management responsibility elements 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. You will lead projects associated with global process harmonization to ensure a fully compliant and efficient QMS

What You Will Be Doing

· Lead and maintain iRhythm’s global Management Review process ensuring compliance with US and international requirements.

· Develop implement and continuously improve the Quality Planning process to align annual quality goals and initiatives with corporate and regulatory requirements.

· Establish monitor and report Quality Objectives and Key Performance Indicators (KPIs) to evaluate QMS performance and drive accountability.

· Lead ownership and oversight of the company’s electronic Quality Management System (eQMS) including system configuration maintenance validation activities and process optimization.

· Ensure the eQMS supports effective control of Quality System processes (e.g. CAPA Complaints Document Control Training Audit etc.) and complies with global regulatory expectations.

· Partner with global cross-functional leaders to ensure harmonized management control processes across all of iRhythm’s markets.

· Coordinate preparation accuracy and traceability of data presented in Management Review and other Quality Systems data review presentations ensuring actions are tracked to closure.

· Maintain and improve the Quality Metrics program ensuring consistent definitions reliable data sources and regular reporting cadence.

· Support internal and external audits and inspections. Serve as the SME for Management Controls and eQMS validation during audits and inspections.

· Identify and drive process improvement initiatives across Quality Systems to enhance compliance data visibility and operational efficiency.

· Mentor and guide team members. Collaborates with mentors and motivates staff for success provides coaching and development based on development needs.

· Maintains QMS processes that are robust alignment with corporate policies and procedures and executed properly across all iRhythm sites.

· Other duties may be assigned as deemed necessary by management.

What We Want To See

· Bachelor’s Degree or equivalent experience.

· At least 10 years of experience in a Quality or Regulatory role preferably in medical devices with at least 7 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 people 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 energetic leader who is motivated to develop and grow a team with integrity.

Location:

Remote - US

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

Estimated Pay Range

$146000.00 - $190000.00

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 [email protected]

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 [email protected]. 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