Principal Quality Assurance Engineer - Field Action Team Lead

 

Additional Location(s): 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.           

 

About the role:

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.  We were also recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

 

As a Principal Quality Assurance Engineer – Field Action Team Lead 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 mentor project managers, shape process improvements, and elevate overall field action capability across Boston Scientific.

 

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.

 

Your responsibilities will include:

● 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, and critical path

● Align and lead cross-functional teams across quality, regulatory, medical safety, legal, operations, and commercial functions

● Establish governance and drive decision-making in complex and ambiguous scenarios

● Ensure compliance with global regulations, including FDA 21 CFR 806 and EU MDR, covering recall strategy, classification, and reporting

● Oversee development and approval of compliant field action communications

● Influence and lead cross-functional teams 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 continuous improvement

 

Qualifications:

 

Required qualifications:

● Bachelor’s degree or equivalent experience with a 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

 

Preferred qualifications:

● 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

 

 

Requisition ID: 628710 

Minimum Salary: $ 102100 

Maximum Salary: $ 194000 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Bo