Principal Quality Assurance Engineer - Field Action Team Lead

Boston Scientific•Arden Hills, MN

1d•Hybrid

About The Position

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. As a Principal Field Action Team Lead (Project Manager) within Global Quality Systems, you will lead complex, high-risk field actions, including product recalls and safety corrective actions, across multiple business units. This senior individual contributor role requires end-to-end ownership of large-scale field actions, combining advanced project leadership, regulatory expertise and cross-functional influence. You will operate with autonomy, guide teams through ambiguity and ensure compliance with global regulations and internal quality systems. In addition to execution, you will play a key role in mentoring project managers, shaping process improvements, and elevating overall Field Action capability across BSC. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Requirements

Bachelor’s degree with minimum of 7 years' experience in a regulated industry, or master’s degree with minimum of 5 years' experience
Minimum of 5 years' experience leading complex cross-functional projects
Expertise in post-market quality systems and field action or recall processes
Proficiency in project management tools, including Microsoft Project, Excel, Planner and Teams

Nice To Haves

Knowledge of global recall regulations, including FDA and EU MDR
Experience leading global or multi-region field actions
Background in post-market surveillance, CAPA or complaint handling
Strong analytical and decision-making skills in complex environments
Experience mentoring or leading project managers
Proven ability to manage multiple high-risk, high-visibility projects
Demonstrated ability to influence across functions without authority
Strong communication skills, including experience with regulators and senior leadership

Responsibilities

Lead end-to-end execution of global Field Actions, ensuring on-time delivery, quality, and regulatory compliance
Own multiple high-impact projects, proactively identifying risks and driving mitigation and escalation strategies
Develop and manage integrated project plans, including project scope, schedule, resources, critical path
Align and lead cross-functional teams across Quality, Regulatory, Medical Safety, Legal, Operations, and Commercial
Establish governance and drive decision-making in complex, ambiguous scenarios
Ensure compliance with global regulations (e.g., FDA 21 CFR 806, EU MDR), including recall strategy, classification, and reporting
Oversee development and approval of compliant Field Action communications
Lead cross-functional teams and influence without direct authority
Mentor project managers and support capability development across the team
Drive process improvements, standardization, and scalable best practices
Communicate project status, resolve issues and ensure on-time delivery
Lead post-action reviews and translate insights into improvements