Complaint Investigator
About The Position
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world: LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death. HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent. TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career. This position is responsible for acquiring and compiling information related to medical device complaint investigations as required by US Food and Drug Administration, European Union Competent Authorities, and other international medical device regulators
Requirements
- Associate's Degree In Life Sciences or a Technical Discipline. required
- Requires a high level of attention to detail and be able to multi-task.
- Ability to operate personal computers.
- Strong knowledge of Microsoft Excel, Word, Outlook, and Adobe Acrobat software.
- Strong typing skills.
Nice To Haves
- Experience with Microsoft Access preferred
Responsibilities
- Compile complaint investigation information including correction, root cause, and corrective action, with supporting documentation, as applicable.
- Timely reporting of adverse events and device malfunctions to external regulatory agencies.
- Time management skills to ensure consistent throughput of complaint processing.
- Liaise with the distributor, service, and engineering departments in acquiring relevant information, for complaint investigations, such as service reports, medical affairs incident event reports, and device data reports.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
