Senior Quality Systems Manager

Additional Location(s): US-MN-Maple Grove; US-IN-Spencer; US-MA-Marlborough

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:
The Sr Quality Systems Manager will lead the Corporate Quality System team in technical expertise as the Process Steward for Document Control, Record Control, and Data Control within a Global Quality System.  The Sr Quality Systems Manager will support the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of processes and systems conform to establish standards and agency guidelines. The Sr Quality Systems Manager will champion all compliance activities within assigned area. The Sr Quality Systems Manager will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. The Sr Quality Systems Manager will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.
 

Your Key Responsibilities will include:

• Act as Corporate Steward for areas of Global Document Control, Record Control, and Data Control.  Leads the sub-process stewards in development and maintenance of process metrics and/or methods, as required, for performance, continous improvement, and monitoring.  
• Lead continuous improvement through the Quality System Steward and Community of Practice model against strategic roadmap plans of activities.
• Implement training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable the Document Control/Record Control/Data Control processes for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
• Manage, coach, and develop a team of document and record control quality specialists
• Lead or oversee quality projects of major magnitude and scope.  Provide input and oversight to overall quality project portfolio and project priorities.
• Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.
• Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.  
• Act as a CAPA owner for corrective actions necessary to improve the global processes as appliable within the global processes

 

Required Qualifications: 

• Minimum of Bachelor’s degree in relevant field 
• Minimum of 7 years Document Control or related experience
• Minimum of 5 years of  direct or indirect management experience
• Understanding of regulations and standards applicable to the BSC Global Quality System and Document, Records and Data Control processes (ISO 13485, 21 CFR 820, EU MDR, etc.). 

 

Preferred Qualifications:

• Advanced degree preferred
• Medical device experience preferred
• Strong analytical and communication skills
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution

Requisition ID: 578217

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.  

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