Sr QE - Risk Management - 23851

Biotechnology and Pharmaceutical Sr QE - Risk Management - 23851 Job Description:Delivering on the promise of medical innovation begins at Boston Scientific By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.Job PurposeAssist in the drafting of a new Risk Management systems strategy (and subsequent execution of that strategy) for BSC. Key Responsibilities Assists in and manages functional and team deliverables. Ensures that contributions maximize Risk Management systems compliance to regulatory requirements, as well as drive efficiency and excellence in product development and commercialization environments. Provides guidance and approval (as applicable) regarding risk management strategies and approaches. Assists in communication of Risk Management team objectives, goals, and subsequent conclusions with (at a minimum) their home function. Communication responsibilities may extend out to include other business units, divisions, etc. depending on how individual is assigned to a role on the final team. Maintains and enhances cross-functional team relationships. This will include working with other Project Horizon teams to insure a real-time communication of issues as related to Risk Management. Work with quality system owners/stewards on strengthening the connection of Risk Management to their element(s) of the quality system Works cross-functionally in identifying and resolving technical issues including modeling activities for the core and/or integrated systems, using project/site/quality system data to ensure effectiveness of the Risk Management system prior to global roll out. Monitors and evaluates project progress and results as assigned. Provide coaching to other functional groups on elements of Risk Management activitiesJob Experience:Qualifications Preferred qualifications include:• 6+ years BSC and/or equivalent medical device industrial experience, with heavy emphasis on usage of Risk Management toolbox (ex: FMEA, FTA, and other Risk Management & Analysis tools.)• Basic experience with risk management planning and reporting per ISO 14971• Proficient, working understanding of primary external regulatory guidance documents around Risk Management (ex: ISO 14971)• Strong systems engineering background – either through educational experience, industrial experience, or both. Examples of systems engineering might come from systems architecture training, product development using a formalized stage gate or iterative process, process mapping training, etc.• Excellent communication skills – must have experience creating PowerPoint presentations and speaking in front of 20+ people. Must be willing to act as primary communication conduit for their respective function and/or division.Minimum Education Required: BachelorExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.