St. Jude Medical Sr. Data Analyst, Postmarket Surveillance in Plano, Texas

Sr. Data Analyst, Postmarket Surveillance


Plano, Texas, USA at

1 additional location

Plymouth, Minnesota, USA

Quality at

Global Operations-Supply Chain-Quality

1600025MRequisition #

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We are seeking an experienced, high caliber Sr Data Analyst for Postmarket Surveillance. This position is responsible for various data analysis activities including: complaints trending, MDR/MDV trending, and providing data reporting inputs for Management Review and various reporting and month end activities.

Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplishgoals.

Impact this role will have on St. Jude Medical:

  • Internal liaison and expert for Complaint Handling database development, maintenance, and sustainment activities

  • Partner with cross-functional Quality and Business Unit Teams to fulfill reporting requirements

  • Includes, but not limited to:

  • Complaints Trending and summaries

  • FDA Medical Device Reporting trending and summaries

  • EU Medical Device Vigilance reporting trending and summaries

  • Weekly, monthly and quarterly product line complaints reporting

  • Support internal and external audits by preparing and providing relevant reports and analysis

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

  • Performs other related duties and responsibilities, on occasion, as assigned

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

  • Bachelor’s degree or equivalent industry experience required

  • 5+ years’ experience in a manufacturing environment

  • Medical Device experience preferred

  • Ability to manage multiple tasks and priorities

  • Strong Microsoft Office capabilities required

  • Experience with automated database systems

  • Knowledge and experience with InfoMed and SAP Enterprise Software highly desirable

  • Ability to query and refine data into summarized results

  • Experience with Microsoft SQL Server, Reporting Services, Analysis Services, a plus

  • Experience working in a broader enterprise/cross-division business unit model preferred

  • Ability to work in a highly matrixed and geographically diverse business environment

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment

  • Ability to leverage and/or engage others to accomplish projects

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

  • Multitasks, prioritizes and meets deadlines in timely manner

  • Strong organizational and follow-up skills, as well as attention to detail

  • Ability to maintain regular and predictable attendance

Your preferred qualifications and education:

  • BS degree in Engineering or Technical Field or equivalent experience;

  • Preferred experience in data retrieval and reporting, advanced database skills

  • Preferred knowledge of SJM complaint handling process and data