Senior Physician Training Quality System Specialist

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

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 Senior Physician Training Quality System Specialist ensures the maintenance of quality assurance programs, policies, processes, procedures, and controls governing the Interventional Cardiology Group Health Care Professional (ICG HCP) Training programs for the Watchman and Accurate products. This is an opportunity to be in a highly visible and influential role. The role is global where you will partner with the Medical Education / Clinical Training team to ensure the efficient and compliant implementation of the physician training process in accordance with medical device standards, regulations & BSC requirements. You will use feedback and data-centric decisions to drive continuous improvement in the process. You will collaborate with Marketing, Sales, Clinical, R&D, and Design Assurance to determine HCP training needs and requirements during early product development projects through commercialization.

 

Your responsibilities will include:

• Be a subject matter expert on the quality aspect of HCP training for internal and external customers
• Supports compliance oversight of the ICG HCP training program to both internal and external regulatory requirements in all applicable geographies
• Identifies and influences continuous improvement efforts to enable the effective global implementation of the HCP training process
• Monitors the HCP training process for products in scope by collaborating with cross-functional partners to ensure the training process and associated records are implemented and maintained appropriately.
• Drive training compliance and use feedback to enable data-driven decisions for continuous improvements
• Leads corrective and preventive actions as required; proactively identifies and executes on opportunities for preventive actions
• Work cross-functionally in identifying and resolving technical and performance issues

 

What we're looking for in you:

Required Qualifications:

• Bachelor’s degree in Science, Health, or Engineering or a relevant field of expertise
• 5-7 years of work experience in the medical device/pharma/ similar regulated industry
• 5-7 years of work experience with quality systems/controlled processes

Preferred qualifications:

• Working knowledge of US and International regulations and standards applicable to BSC
• Experience in the Medical Education space
• Experience with BSC IS systems (e.g. eCAPA, Windchill, APPROVE) desirable
• Experience working with cross functions such as Regulatory, Research and Development, Clinical, Medical, Sales Training and Quality
• Strong presentation skills

 

Requisition ID: 589795

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, creat