Data Analyst, Post Market Complaints

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:

About this role:

iRhythm Technologies Inc. is seeking a Data Analyst to support postmarket surveillance complaint handling and Quality System performance through data analysis reporting and visualization. This role is responsible for executing routine to moderately complex analyses using established tools methods and frameworks to support trending investigations and regulatory reporting activities.

The Data Analyst partners closely with PostMarket Quality and crossfunctional stakeholders to ensure data integrity timely reporting and clear communication of insights. Working under defined analytical standards and guidance this role contributes to inspection readiness management reviews and continuous improvement initiatives by transforming postmarket data into accurate actionable information.

Responsibilities:

• Design create and verify data reports metrics and visualizations of post-market surveillance data
• Support and facilitate postmarket surveillance data reviews under established frameworks
• Support complex investigations by performing analyses using defined methods
• Prepare analytical content for regulatory submissions under guidance and review
• Coordinate analyses of post-market data to identify and investigate product quality concerns
• Apply statistical techniques to test hypotheses in support of investigations and corrective and preventive actions (CAPA)
• Identify and recommend system and process improvements to enhance efficiency and effectiveness of data analysis activities
• Participate in regulatory audits internal audits and inspections to represent post-market surveillance analytics
• Perform other quality and regulatory-related duties as assigned

Required Qualifications:

• Bachelors Degree or Associate Degree in engineering science or technology
• 3 years of experience in business manufacturing data analytics data modeling or statistical modeling in a cGMP related industry
• Strong ability to acquire and manage data from enterprise systems
• Demonstrated proficiency with a business intelligence package such as BI tools such as Business Objects suite and Data Management tools such as Tableau
• Familiarity with at least one statistical programming package (e.g. Minitab) preferred
• Previous experience in medical devices with working knowledge of ISO 13485 FDA 21 CFR 820 European Union MDD /MDR
• Strong analytical problem solving and presentation skills and strong attention to detail
• Ability to work as part of a diverse team
• Effective verbal and written communication skills

This is a fulltime position. iRhythm offers a competitive salary and comprehensive benefits package.

Location:

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.

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 @ email address. Please check any communications to be sure they come directly from @ 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 Written offers of employment will be extended in a formal offer letter from an @ email address ONLY.

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