Quality Director - Urology

Diversity - 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 role:The Director of Divisional Quality- Urology is an exciting opportunity to lead the Quality team supporting the Urology division at Boston Scientific. They will have primary Divisional Quality leadership/oversight for the rapidly growing Stone Management and Laser Therapies franchises. This role is located at the Marlborough, MA site.The Director of Divisional Quality- Urology is responsible for leading a team in developing and sustaining single use devices (SUD) as well as SUD/capital equipment systems in growing and innovative businesses. This Director will be responsible for ensuring product quality and compliance through leading the application of design controls, usability, and risk management. They will also be a key partner to the R&D, Regulatory, Post Market Quality, Supplier Quality, Clinical, Marketing, and Process Development teams in achieving new product development, commercialization, and product sustainment deliverables.Your key responsibilities will include:Ensure product safety, reliability and high quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product life cycle.Ensure efficient compliance to all applicable regulations through the implementation of a robust company quality system and through communication/reporting to regulatory authorities.Lead a team of employees in executing the organization’s mission, core values, and behaviors as well as achieving organizational goals. Recruit, coach, develop and motivate a high performing team.Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture.Keep the organization's vision and values at the forefront of decision making and action, including directing and controlling the activities and budget.Lead the Quality team on development projects of major magnitude and scope. Key quality voice of influence on new product development projects.Own and drive commercial product monitoring and all related product sustainment activities.Assure continuous improvement in product performance by incorporating learnings into new product development.Employ lean methodologies to improve the efficiency of the Quality System.Create an entrepreneurial environment and demonstrate effective change leadership.Directly interface with regulatory authorities, including internal and external audits.What we're looking for in you:Required QualificationsMinimum of a Bachelor's degreeMinimum of 9 years of Quality engineering experience in a medical device or regulated environment or similar related work experienceMinimum of 5 years of direct or indirect management experienceDemonstrated ability to lead effectively across a broad and diverse body of work/functions/sites.Experience as a strong inclusive leader with proven experience collaborating with peers and network.Preferred Qualifications:Advanced degree preferredFamiliarity and experience with BSC design control systems and methodsFamiliarity with BSC products and customer needsLean business/VIP experienceRequisition ID:

594169

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