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Post Mkt Surveillance Engineer - Draeger, Inc. - Job-ID V000004004

Company: Draeger
Location: Lynn
Posted on: November 20, 2020

Job Description:

What will you do At Draeger, our work is dedicated to protecting, supporting and saving lives. We are looking for a talented individual to join our patient monitoring team to help deliver new features and product enhancements that will improve patient outcomes and reduce the cost of medical care around the world. This team member will be responsible for evaluating potential complaints, initiating timely actions in association with investigating or coordinating the investigation to complaint closure. Assure applicable, local, national and international regulatory requirements are met. Support field safety corrective actionsrecalls, as required. Receive potential complaints and conduct an investigation of an assigned product quality issue, from data collection to investigation summary, including coordinating implementation or recommendation of CorrectivePreventative Action(s), when required. Coordinate and monitor the efforts of assigned investigatorssub investigators including follow up actions to ensure timely and effective investigation results, provide direction as needed. Work independently andor cross functionally with various departments (e.g. regulatory offices, local subsidiaries, field service personnel and clinical engineering personnel), as well as complainant, to collaborate, gather and evaluate details of the technical investigation information in order to effectively establish the cause of the quality issue and ensure a clear, concise and complete investigation report is prepared. Examine complaint data to determine trends that result in corrective action, report complaint trends to management and assist in post market compliance activities, including field safety corrective actionsrecalls related to complaints. Investigate, review and summarize the results of Engineering, Manufacturing, Quality, Service or Supplier evaluations and investigations. May participate in Cross Functional Team meetings or Process Improvement teams. Monitor the status and progression of complaints under investigation. Monitor the Return Goods associated with complaints for efficiency and effectiveness. Provide feedback concerning areas of deficiency. Assist Regulatory Affairs in FDA inspections, ISO audits, internal audits, Trackwise training, andor suggestionsfeedback regarding process improvements). Provide detailed Database reports andor complaint status information, as required. Performs other duties as needed and assigned. Who you are Education Bachelor's Degree preferably in scientific, healthcare, nursing or related field - or the equivalent in education, experience and training. Related Experience A minimum of 5 years of data collection, analysis, trending and reporting experience in a regulated industry. Medical device experience preferred prior experience in the medicalclinical area is desired. Special Competencies or Certifications Excellent verbal and written communication skills. Analytical approach to problem solving Well organized and able to multitask effectively, as well as show assertiveness, when interfacing with other personnel during the complaint investigation process. Microsoft Office and database skills are required.

Keywords: Draeger, Lynn , Post Mkt Surveillance Engineer - Draeger, Inc. - Job-ID V000004004, Other , Lynn, Massachusetts

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