Quality Director - Urology

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 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 demonstrates effective change leadership. Directly interface with regulatory authorities, including internal and external audits.What we're looking for in you:Required Qualifications Minimum of a Bachelor's degree Minimum of 9 years of Quality engineering experience in a medical device or regulated environment or similar related work experience Minimum of 5 years of direct or indirect management experience Demonstrated 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 preferred Familiarity and experience with BSC design control systems and methods Familiarity with BSC products and customer needs Lean business/VIP experienceRequisition ID: 594169Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal of the drug testing is to increase workplace safety in compliance with the applicable law.As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 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.Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.