Quality Vice President, Cardiology + Ireland Manufacturing

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At 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.           

Location: Maple Grove, Minnesota

About the role: 
Boston Scientific is recruiting for a vice president to join our Global Quality team as a critical member of the Quality Leadership team and lead the integrity of all Quality for Boston Scientific devices for the Interventional Cardiology (ICTx) and WATCHMAN™ businesses as well as three Ireland manufacturing sites. This individual will collaborate with senior leadership teams in the businesses to establish and ensure product quality and compliance strategies through the full product lifecycle.  This vice president will also act as a liaison between the company and various regulatory agencies around the globe. A vice president, senior directors and directors report into this role.

Your responsibilities will include: 

• Provides a global vision, strategic plan, and leadership for the ICTx and WATCHMAN™ businesses as well as three Ireland manufacturing sites’ Quality organizations.  Determines business unit/plant Quality objectives and links those objectives to division, plant, and corporate objectives. 
• Develops, establishes, and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure lasting customer satisfaction.  Will participate in Quality Master Planning (QMP) process as required. 
• Serves as a member of the Quality senior leadership team.  This body is responsible for developing and reviewing metrics indicating the functioning of the Quality System, advising on the development of SOP’s and other policies, and making recommendations for improvements to the Quality System and the overall Quality organization. 
• May serve as the Management Representative for the designated businesses and associated site(s): maintain compliance to Corporate Quality Management System; manage and maintain effectiveness of Quality Management System; represents the business or site to outside regulatory bodies; ensures submittal to the company a monthly report summarizing trend analysis on their defined and applicable quality system clauses and corresponding quality objectives via the Management Review System; facilitates the awareness of regulatory and customer requirements throughout the organization. 
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation. 
• Leads collaboration with multiple cross-functional partners to ensure achievement of standards and regulations during product development, acquisition, and commercialization activities. Oversee execution of these strategies; adjust and collaborate to ensure mutual success.  
• Represents Quality function on group/division management board and influences executive decision making regarding prioritization of all projects to obtain critical resources and funding for projects. 
• Develops and manages (directly and indirectly) relationship and interface with global regulatory agencies. 
• Create infrastructure to monitor health of processes and consistent ability to achieve performance targets and goals.  Provides divisions and regions with updates on pending changes in regulations and corresponding processes and provide guidance on how to prepare for changes.  
• Builds a global organization that is efficient, effective and meets global strategic needs.   
• Determines and establishes division/site Quality organizational structures, allocating/re-allocating internal and external resources, as needed to ensure the appropriate QA organizational structure is in place. 
• Fosters a diverse, inclusive, patient-centric culture that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives. 
• Coaches, develops and mentors Quality employees to ensure their ongoing career development. Ensure fulfillment of employee training requirements. 
• Create an environment that encourages constructive feedback and coaching, understanding of individual career goals and aspirations, and proactive developmental support for all employees. 
• Identify and evaluate critical positions within the function and establish strategies to develop strong talent pipelines and robust succession plans. 

 
Required Qualifications: 

• Minimum of a Bachelor’s degree  
• Minimum of 15 years of direct Quality Assurance experience, with at least 3 years at the vice president level 
• Minimum of 10 years of direct managerial experience 
• Direct, relevant experience leading global teams 
• Experience managing complex, matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization 
• Experience in direct interaction/established relationships with global regulators  
• Proven experience in developing Quality strategies, ensuring effective implementation across the organization, including converting the strategies to meaningful and motivating goals and objectives, into and across the Quality organization 
• Demonstrated commitment to creating an inclusive and high-performing culture, embracing diversity, equity and inclusion  

Preferred Qualifications: 

• Advanced degree 
• Medical device experience 
• High degree of integrity, professionalism and ability to establish credibility internally and externally 
• Strong leadership skills with the ability to influence and build relationships with a high customer focus 
• Commitment to organizational effectiveness and team and individual development 
• High sense of urgency and commitment to execution 

#LI-Hybrid

Requisition ID: 600804 

Minimum Salary: $300,000

Maximum Salary: $400,000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 status, age, mental or physical disability, genetic information or any other protected class.

Among 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.