Job Description
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. Apply tot his job