Principal Quality Assurance Engineer - Field Action Team Lead

Boston Scientific • Arden Hills, MN

9d • Hybrid

About The Position

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.
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 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

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, 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

Benefits

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
• Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
• At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior