Quality Specialist – Post Market

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $74k - $93k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 0%

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Logo of iRhythm Technologies, Inc.

iRhythm Technologies, Inc.

1001 - 5000 employees

Founded 2006

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

📋 Description

• Independently evaluate complaints to determine reportability in accordance with USA, European and Japan adverse event reporting requirements with guidance • Perform and/or coordinate moderately complex complaint investigations in a timely manner • Analyze technical information to support root cause assessment using established methods • Collaborate cross-functionally to complete investigations • Identify trends and/or issues for escalation • Identify opportunities for and support process improvements • Perform other quality and regulatory-related duties as assigned • Manage routine to moderately complex complaints • Perform day-to-day complaint review, investigation reports, adverse event reporting, and complaints log and trend maintenance

🎯 Requirements

• Bachelor’s Degree or Associate Degree in science, technology or medical fields • 2 years of experience in Quality Assurance and / or a complaint processing role • Working knowledge of applicable global medical device regulations, particularly as they relate to complaint handling, vigilance, reporting timelines, and post-market surveillance • Strong written and verbal communication skills

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