VP, Quality - LATAM Manufacturing

Additional Locations: This position can sit at any BSC manufacturing site in Costa Rica 

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.

About the role:
This Regional Manufacturing Quality Vice President will have oversight of the manufacturing Quality functions operating within their respective regional sites, and overall accountability for the quality of the products manufactured within those sites. The Regional Manufacturing Quality Vice President will partner closely with the Global Supply Chain (GSC) VP of manufacturing for the region, as well as the other regional Quality Manufacturing VPs globally to assure achievement of regional and global goals, and best practice sharing across the Boston Scientific (BSC) sites for overall network success. The Regional Manufacturing Quality Vice President will ensure continuous improvements to processes and products and will leverage an internal and external network to assure BSC’s standing as best in class in the medical device manufacturing domain.  The Regional Manufacturing Quality Vice President acts as a liaison between the company and various governmental agencies and notified bodies around the world in assuring compliance to global and regional regulations and standards at their respective manufacturing sites.  The Regional Manufacturing Quality Vice President will serve as a member of the Quality Leadership team and will represent assigned sites to shape the direction of BSC’s quality system.  

Your responsibilities will include:

• Responsible for the Quality organization at their designated manufacturing sites.
• Provides a regional vision, strategic plan, and leadership for the Quality organization and determines business unit/plant Quality objectives and links those objectives to division, plant, and corporate objectives, as well as to key Quality system aims.
• Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company, international, and governmental regulatory standards and agency guidelines, and to ensure lasting customer satisfaction.
• Creates infrastructure, develops and reviews metrics to monitor health of processes and the overall adequacy and function of the Quality System; assures consistent ability to achieve performance targets and goals.
• Ensures processes and infrastructure are in place to enable the continuous improvement of the execution of the quality system at their designated sites.
• Advises on the development of SOPs and other policies and makes recommendations for improvements to the Quality System and the overall Quality organization. 
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assists the organization in driving implementation. Keeps leadership teams/ regions abreast of updates on pending changes in regulations and corresponding processes and provides guidance on how to prepare for changes. 
• Develops and manages (directly and indirectly) relationship and interface with the regulatory agencies (domestically and internationally).
• Designated Quality Systems Management Representative in place of the VP, Global Quality (Divisional), when required.
• Designated to approve key quality system documents in place of the VP, Global Quality (Divisional), when required.
• Collaborates with multiple cross-functional colleagues to ensure achievement of standards and regulations during product development and commercialization activities.
• Determines and establishes Quality organizational structure and supervisory relationships.  Coaches, develops and mentors Quality employees.  Will allocate/re-allocate resources, as needed to ensure the appropriate QA organizational structure is in place to execute on commitments.
• Ensure fulfillment of employee training requirements for their designated Manufacturing sites.
• Leads the advancement of manufacturing sites adopting best practices and harmonizes processes across sites.
• Represents Quality on regional GSC leadership teams and influences decision making regarding prioritization of projects/programs to obtain critical resources and funding.
• Builds an organization that is efficient, effective and meets regional strategic needs.  
• Fosters a diverse, inclusive, patient-centric culture that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives.
• Creates an environment that encourages constructive feedback and coaching, understanding of individual career goals and aspirations, and proactive developmental support for all employees.
• Identifies and evaluates critical positions within the function and establishes strategies to develop strong talent pipelines and robust succession plans.
• Identifies and evaluates critical positions within the function and establish strategies to develop strong talent pipelines and robust succession plans.
• Collaborates closely with other regional VPs of Manufacturing Quality to develop strategies, align priorities, and coordinate the implementation of initiatives that enable product performance and drive compliance.

Required Qualifications:

• Minimum of a Bachelor’s degree 
• Minimum of 10 years of direct Quality Assurance experience, with at least 4 years at the Senior Leadership level
• Minimum of 10 years of direct managerial experience
• 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 & objectives, into and across the Quality organization
• Demonstrated commitment to creating an inclusive and high-performing culture, embracing diversity, equity and inclusion 
• Strong leadership skills with the ability to influence and build relationships with a high customer focus
• Commitment to organizational effectiveness and team & individual development

Preferred Qualifications:

• Advanced degree preferred
• Global experience preferred
• Medical device experience preferred
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution
• Fluent in Spanish preferred, but not required

Requisition ID: 616689

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!