Boston Scientific Associate Director Quality Manufacturing 

United States, Minnesota, Arden Hills 

640086455

The Associate Director of Quality will lead a team of managers, supervisors, and engineers to support manufacturing, new product development, post-market investigations, and Quality Systems for capital equipment and other medical device electronic assemblies. Key tasks include directing and prioritizing Quality signals and improvement projects to ensure the manufacture and delivery of high-quality products and facilitate compliance with regulatory requirements while partnering with Production, Engineering, R&D, and Process Development. Also, ensuring new products are implemented with key process controls, product checks, and preventative activities in place. It will be imperative for this leader to build collaborative partnerships across the functions to ensure strategic and organizational objectives are met.

Key responsibilities include:

• Build collaborative partnerships with core business operations to ensure success amidst the growth of Capital Equipment Operations.
• Work strategically to identify and align new business according to new standards for In-House Repair Activities.
• Provide support to Global Network Service Locations and Capital Equipment Technical Services Operations.
• Leads team(s) / department(s) of senior level professionals and/or subordinate managers focused on execution of operating plans.
• Leadership complexity is typically characterized by diversity and complexity of activities, scale of decisions and/or divisional/regional.
• Develops and executes own strategy and budget/P&L to achieve key area objectives.
• Directs and sets business, technical and operating standards for team(s) / department(s) managed.
• Applies critical thinking to recommend products, programs, standards and operating strategies that drive improvements.
• Requires deep, advanced knowledge of theories, concepts, principles and systems in multiple related professional job functions; requires comprehensive understanding of industry standards to adapt departmental plans accordingly.
• Sets the best practices and functional/technical direction for the job function within the context of assigned responsibility within a team / department / area.
• Demonstrates effective change leadership.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Provides appropriate level of cross-functional and customer-oriented communications regarding the status of department and quality system operation, as well as product performance.
• Applies and leverages comprehensive knowledge of the industry/ business environment/sector in which BSC operates and applies that understanding to create a competitive advantage and drive financial and operational performance for a significant portion of an area.

Required Qualifications:

• Minimum of a Bachelor’s Degree.
• Minimum of 10 years of related functional and leadership experience within the Production/Operations space.
• Minimum of 5 years of direct managerial experience leading large and diverse teams across a highly matrixed organization.
• Medical device or related industry experience.

Preferred Qualifications:

• Trained and experienced in BSC Quality System or equivalent.
• Prior Manufacturing experience.
• Training and experience in Lean / DMAIC / Engineering Essentials methodologies.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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.