Senior Supplier Quality Engineer

Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.About The RoleThe Senior Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet Boston Scientific’s requirements. Additionally, the Supplier Quality Engineer will support global sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. The Sourced Finished Medical Devices (SFMD) Supplier Quality Engineering team is looking for high energy, driven, passionate people, looking to not just change jobs, but start an amazing career!Your Responsibilities Will IncludeAssess suppliers for technical, quality and manufacturing capabilities. Assess supplier changes for product and compliance impactResponsible for supplier qualification, onboarding and performance monitoring based on supplier risk, Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design AssuranceGenerate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validationsPlans and leads ISO 13458 focused audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including determining assessment outcomes and driving corrective actions/proactive preventative actions to closureEvaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentationDevelops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unitPlans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedulesWorks under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectivesEstablishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutionsIn all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality SystemChampions 100% compliance to company policies and SOP’s. Identifies and advises management on potential improvements to quality systems and processes in the companyRequired QualificationsBachelor's degree in engineering/technical field such as materials science, chemical or mechanical engineering and 5 years related experience Experience with problem solving quality tools and CAPAExperience in working with mechanical or electrical suppliersDomestic and international travel up to 10%Experience with technical documentationExperience in process validation, design controls, risk management, and CAPAPreferred QualificationsAbility to communicate & influence cross functionally, with suppliers, team members and leadershipArticulate communicator: adept at messaging and appropriately scaling information to the intended audienceAbility to work independently; organized and self-drivenAbility to rapidly learn and use new software applications (e.g., PLM, ERP)Leadership experience on a materials or service commodity teamLead auditor of quality systems experience (ISO 13485 or similar)Experience with auditing supplier quality systemsASQ certification (CQE, CBA, SSGB, SSBB) strongly desired7 years of related experience Requisition ID: 590975Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.