Description:The Sr. Data Analyst will collect, analyze, report, and monitor data and key process metrics related to Post Market Surveillance system. The general scope of this position will be related to analysis of complaint failure modes, harms, frequencies, and identification of any patterns within the data using statistical control charts, Pareto’s, etc. and high-quality data presentation skills to ensure information is presented in a clear and concise manner. This role will also provide support as needed for various Quality System processes for the purpose of periodic analysis and review of quality data for input into various quality metrics within the Quality System. This work is accomplished with limited supervision and required and motivated, self-starter who can work independently.Essential Job Functions Support Post Market Surveillance activities by extracting and analyzing post market surveillance data to support the Post Market Surveillance plan(s)/report(s), Periodic Safety Update Report(s) for submission to regulatory bodies as applicable. Conduct comprehensive literature searches, review of complaints, CAPAs, and adverse event and clinical databases, and develop methods to efficiently extract and summarize in a report for our Medical Devices or similar devices. Conduct searches of the MAUDE database on a periodic basis. Assist in establishing Key Performance Indicators to measure effectiveness of the Post Market Surveillance (PMS) process. Develop and perform effective data analysis and visualization for all elements of the (PMS) system and processesDevelop and generate reports and analysis
o Create presentations based on the data setso Collaborate with various functional teams to collect and analyze datao Use graphs, infographics, and other methods to visualize datao Collect and analyze QMS data for Management Review and other periodic reviews Assist in monitoring, detecting quality and safety signals associated with product performance, and overall aspect of the PMS and Quality Management System (QMS). Provide support as needed for periodic analysis and review of QMS data such as data for final product release activities, non-conformance system management, CAPA, audits, supplier. This position requires frequent use and general knowledge of industry practices, techniques, regulations, and standards. In compliance with FDA, ISO13485:2016, European MDD/MDR & other International Regulations Assist functional teams to identify opportunities for improvement Assure data integrity and data validation prior to publishing reports and analysis Process confidential data and information according to guidelines Manage and design the reporting environment, including data sources, security, and metadata Support the data warehouse in identifying and revising reporting requirements Support initiatives for data integrity Support implementation of the new/upgraded software, new products, and new country requirements Troubleshoot the reporting database environment and reports Train end-users on new reports and dashboards Provide technical expertise in data storage structures, data mining, and data cleansing Identify and drive QMS continuous improvement activities Support company goals and objectives, policies, and procedures, QSR, and FDA regulations Other duties as assignedSkills:Data, Data analysisAdditional Skills & Qualifications: BS degree in computer science, statistics, mathematics or related areas Minimum 5+ years’ experience directly supporting PMS/QMS data analysis, or relevant experience in medical/scientific area Strong background in statistics Proficiency in SAS that includes the use of a variety of statistical procedures is preferred Required knowledge of Medical Device Quality Systems (FDA QSR, ISO 13485, EU MDR etc.) Ability to work effectively with cross functional teams to assess potential risks Ability to analyze existing tools and databases and provide software solution recommendations Ability to translate business requirements into non-technical terms High-level experience in methodologies and processes for managing large-scale databases Demonstrated experience in handling large data sets and relational databases. Excellent critical thinking skills Effective written, verbal and presentation skills with all levels of management and organizations Advanced Microsoft Excel and PowerPoint skills with the ability to manipulate data and use advanced formulas Operates both as a team and independently, with adaptability to changing requirementsAbout Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.