JOB REQUIREMENTS: ·          Requires advanced Microsoft Excel skills ·          Experience with Microsoft Office suite and Microsoft Outlook preferred ·          Experience with Document Management systems a plus ·          Good writing skills with the ability to explain data analysis required ·          Experience working in regulated environment (cGMP, ISO13485, etc) preferred ·          General working knowledge of Quality Systems (NCR, CAPA, Customer Complaints, Document Control, etc) ·          General working knowledge of Design Controls (FDA Quality System Regulation Part 820) ·          Candidate must be able to interact and communicate effectively with engineers and other functional professionals at all levels. ·          Requires the ability to work independently with little to moderate direction ·          Candidate must be very organized with good time management and be able to simultaneously support multiple projects / project teams.   JOB DESCRIPTION: ·          Candidate must be able to independently perform the following: ·          Support the Legacy Post Market Surveillance project – obtain, analyze and report complaint and sales data, CAPA and Non-conformance histories, and competitive product complaint data ·          Work with Quality Engineers and Regulatory Affairs associates effectively to complete both Post Market Surveillance and Risk Management reports in the defined project timeline ·          Ensure that all reports conform to the current procedures and are created and release in the document management system     Please Note: Submit your resume through this posting. Please Do Not Call, we will call you. ======================================================== Pioneer Data Systems, Inc. an "Inc 500" and "NJ Technology Fast 50" company, is a preferred provider to Fortune 500 Clients nationwide. We distinguish ourselves by providing outstanding service to our clients using emerging and innovative technologies. PDS offers excellent compensation, benefits and   constant flow of new challenges to its consultants. We understand that every professional has different needs, so we will work with you to determine a suitable benefit package, which includes;   group medical plan (Section 125), 401K Plan, etc. We are an E-Verify Employer. For further information, please visit us at   www.pioneerdata.com