Post Market Survelliance Analyst - Remote (Entry Level or 3 Years Exp)

Position : Post Market Survelliance Analyst Location : San Diego, CA Duration : 12 Months Total Hours/week : 40.00 1st Shift Client : Medical Devices Company Job Category : Engineering/Technical Level of Experience : Mid-Level Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Summary Job Description: The Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers and analysts in support of post market surveillance processes. Responsibilities ? Conduct post market product data analysis and aid in creating necessary post market documentation such as post market surveillance plans and reports ? Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required. ? Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management. ? Reviews and continuously executes the post market surveillance process. Extracts monthly post market quality data and helps in update of PMS reports ? Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection. ? Summarizes trends, signals, and escalations. ? Ensures appropriate identification and governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate. ? Completes projects/other duties as assigned. Provides support during external and internal audits of the post market surveillance processes. Skills And Competencies ? Excellent written and verbal communication skills ? Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment ? Project management skills and the ability to maintain excellent electronic records ? Intermediate to advanced MS excel skills (Pivot tables, Vlookup, formulas). ? Ability to effectively collaborate with team members across functional areas Qualifications And Experience ? Bachelor?s degree in mathematics, engineering, business or related field ? An advanced degree (MBA or MS) and a concentration in a technical, scientific, engineering or related field is preferred ? Minimum of 2 years of relevant business experience ? An understanding of basic statistical analysis software packages (SAS, R, SPSS, SQL) is preferred. ? A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required. ? Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred. ? Experience with analysis and signal detection in a large data set is preferred. ? Understanding of Risk Management is preferred. ? Prior experience in the medical device industry or an FDA regulated environment is preferred. ? Experience with Complaint Management System and technical documents is preferred.