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Senior Data Analyst – Post Market Surveillance.
Ref No.: 19-11247
Location: Neenah, Wisconsin
Our client, a leading fortune company is looking for a Senior Data Analyst – Post Market Surveillance. This is for an initial duration of 6 months and is located in Neenah, WI

Job Description:
Position Specific Accountabilities:
  • Analyzing complex issues considering reliability statistics when appropriate and clinical impact Defining complaint thresholds for field performance monitoring, trending, and issue escalation;
  • Evaluating field performance, analyze field performance trends, and recommend corrective action when necessary.
  • Assisting the manager in ensuring all medical device reports are filed within regulatory timeframes Reports and discusses trends in product/process categories with Quality Assurance, Regulatory Affairs, & Research & Engineering team members/leaders.
  • Execute assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Decision Tree Completion, Final Review, and Sample Evaluation. Flow to Work to assist others as needed.
  • Provides training on complaint reporting to other groups.
  • Provides training in Product Surveillance product complaint handling Supports complaint database upgrades, changes, conversions through design input, testing, maintenance functions Act as the owner of one or more quality sub-systems (within Post-Market Surveillance), making recommendations and decisions on changes to standards, providing training to users, and supporting implementation as needed.
  • Identifies need for, develops, and executes continuous improvement plans for the assigned sub-system(s) to deliver business results.
  • Builds and maintains capability within the assigned sub-system for compliance with QMS, ISO, and FDA GMP's.
  • Act as information resource to other Product Surveillance team members Collaborate independently with other team members and departments needing product complaint information Conduct investigations with customers or PMS team members with minimal direction, utilizing experience and knowledge of products and various types of product complaints Prepare and provide monthly reports to trend key quality measures, as assigned.
  • Provide mentoring to Quality teams members to ensure growth in data analysis/evaluation Build daily, weekly, monthly, quarterly, and annual reports, presenting data in charts, graphs, and tables. Perform data analysis in support of ad-hoc and standing customer requests
Qualifications/Education/Experience Required:
  • Requires a Bachelor's degree with 5-7 years of data extraction/analysis experience within a regulated industry or Master's degree in mathematics, statistics or engineering with 3-5 years of data analysis experience.
  • Applies broad complaint handling knowledge and experience along with advanced knowledge and practical experience of data extraction and analysis within the context of a similar industry or type of organization.
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.