St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 05:07:32.899879USASt. PaulAnalyst, Product Surveillance Job Requisition #: 13012 Date Posted: 05/01/2012 Category: Quality Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Overview: The Product Surveillance Analyst is responsible for performing evaluations of returned St. Jude Medical Cardiovascular Division products, including heart valves and valve repair products, and other CVD products as requested. The Analyst coordinates product testing/analysis with other CVD departments and external consultants, prepares technical reports of findings and customer letters, operates and maintains the Product Surveillance Laboratory and equipment, and collects and evaluates analysis information. The PS Analyst monitors product performance as it relates to the evaluation of products and is key in identifying potential areas of concern. Responsibilities: • Records condition of returned products including observations, photographs • Coordinates product testing/analysis with other CVD departments and external consultants • Prepares technical reports of analysis/findings • Records evaluation/testing information within the complaint database, as appropriate • Collaborates with cross-functional groups (e.g. Quality Engineers, R&D) on evaluation trends or findings and participates in complaint review groups and risk management activities, as requested • References technical product specifications, Device History Records, or measurements obtained • Utilizes safe biohazard and chemical handling practices at all times • Is diligent in observing for any unusual trends in product complaints • Archives complaint records or returned products & retrieves information on previous investigations • Supports complaint database upgrades and conversions by providing input and performing system testing • Ensures accurate department procedures and work instructions are maintained • Support inspections by external regulatory agencies (e.g. FDA, Notified Body) as requested Requirements: • Four-year degree in science or technical field, or two-year degree and relevant experience supporting product analysis or complaint handling investigations • Solid written and verbal communication skills • Able to work independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously • Strong problem-solving skills • Strong computer skills Preferred Qualifications: • Medical terminology • Anatomy and physiology • Experience with various lab equipment (e.g. microscopic photography, biological cabinet) • Experience handling biohazard specimens and knowledge of universal precautions Report Comments |E-mail this position Submit Resume or C.V.2012-05-01 19:15:45United StatesSt. Jude MedicalMinnesota13012MNSt. Paul, MN28305216http://jobs.sjm.com/xml/28305216/job