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MALLINCKRODT ENTERPRISES, LLC Product Support Specialist in Saint Louis, Missouri

JOB DESCRIPTION Summary This position is a full time position responsible for delivering Clinical Technical Support for the Therakos Extracorporeal Photopheresis ECP product marketed on a World-Wide basis. This position conveys operational, customer service and troubleshooting elements to support and enhance the Therakos ECP instrument in addition to influencing new product designs and enhancements to ensure safety, reliability and overall quality. In this role, the Technical Specialist will be responsible for maintaining the day-to-day activities related to the support of the clinical devices that will include, but are not limited to, providing point of care telephone support during regular business hours, maintaining support records in accordance with current regulations, interfacing with Pharmacovigilance, and providing follow-up to customers regarding technical and/or clinical issues. In addition, this role will contribute to Clinical Research and Device Development activities for marketed and pipeline products upon request. Essential Functions * Provide real-time point of care telephone support during regular business hours and during scheduled on call time mobile phone will be provided and document the details of the call via in the company database * Maintain and continually update customer service request records in SAP, evaluating each record for customer complaints, then entering to the complaints database information relevant to the follow-up and resolution of commercial or research-related technical complaints/issues. * Proactively generate account specific issue reports and work collaboratively with the Medical Affairs field teams to address issues identified. * Participate in device failure investigations by gathering customer feedback and information then appropriately escalating as indicated, interfacing directly with the service and engineering staff. * Perform as use case subject matter expert for follow-up calls with the Safety and Quality groups, gathering additional use case information from customers for AE and MDR reporting. * As required for the product supported, provide support and backup to the afterhours support team including afterhours reference support, provision of updated reference materials, provision of feedback for process and work flow improvements and scheduling. * Review/analyze customer support contact records received includes reports received directly in-house and those fielded by external technical consultants as applicable to ensure consistency and completeness as required for the product supported. * Confirm resolution of all technical support complaints/issues and provide follow-up as appropriate verbally or complaint response letter to the reporter * Communicate device-related issues cross functionally to the Director, Product Support and Technical Services, internal customers i.e., Quality Assurance, Pharmacovigilance, Operations, and Customer Service. * Leveraging subject matter expertise, perform as a SME for instrument reviews, including basic theory of operation training for internal stake holders to ensure customer /patient/business needs are being met. Minimum Requirements * Demonstrated knowledge and understanding of the Therakos Cellex photopheresis instruments. * Holds a current Therakos ECP Operator certificate with experience managing active photopheresis systems in a hospital or clinic environment, including patient monitoring, user support and training. * A demonstrated ability to understand technical information related to medical devices with strong attention to detail, quality and GDP practices. * Communication and interpersonal skills with a demonstrated ability to communicate ideas and information. Daily contact with confused, concerned or irate customers is the norm-confident demeanor and poise is required. * Basic computer skills Microsoft office applications preferred- Microsoft Word, Excel, PowerPoint and Outlook, Internet Explorer or the like. * Must displ