VP, Quality- North America Manufacturing

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills

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.

 

VP, Quality - North America Manufacturing
Location: Arden Hills or Maple Grove preferred, must be at a North America BSC Manufacturing Site

 

*Application deadline: January 25, 2024

 

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) relationships and interfaces 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.
• Ensures 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