Senior Quality Engineer - Global Post Market

Senior Quality Engineer
- Global Post Market Support

Onsite Location(s):
Arden Hills, MN, US, 55112

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

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 are seeking a Senior Quality Engineer – Global Post Market Support to establish, maintain and continuously improve process controls that ensure the reliability of critical outputs from the post‑market complaint handling process. In this role, you will provide quality oversight to support compliance with FDA and other global regulatory requirements while driving process effectiveness, stability and continuous improvement.

Boston Scientific was 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.

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.

Your responsibilities will include:

• Establish robust process controls for complaint handling outputs to ensure alignment with customer requirements and maintain reliable process performance.
• Apply expertise in quality control, statistical methods and systems thinking to drive continuous improvement of the complaint handling process.
• Evaluate the end-to-end complaint handling process, from intake through adverse event reporting, to identify systemwide dependencies, bottlenecks and potential failure modes and proactively mitigate risk.
• Lead and participate in root cause investigations for recurring process failures and implement effective corrective and preventive actions (CAPAs).
• Collaborate with the Complaint Handling, Post-Market Surveillance, Risk Management, and IT and Systems teams to support process effectiveness and compliance.
• Provide technical leadership to a team of global and divisional subject matter experts responsible for monitoring the complaint handling process.
• Coordinate with global and divisional teams to create and maintain clear documentation, including standard operating procedures (SOPs), work instructions and control plans, to support consistency and compliance with medical device regulatory requirements.
• Collect, analyze and report key complaint handling process outputs and trends to senior management.
• Translate customer needs into process requirements for critical outputs, such as complaint codes, ensuring downstream users have reliable information for analysis and decision‑making.

Qualifications:

Required qualifications:

• Bachelor's degree in industrial engineering, statistics, sciences or a related technical discipline.
• Minimum of 5 years' experience in a quality control-related role within a regulated industry, preferably medical devices or pharmaceuticals.
• Experience with statistical process control (SPC) and other statistical tools for quality data analysis, with an emphasis on applying SPC to business processes.
• Experience managing cross‑functional projects in a regulated environment.

Preferred qualifications:

• ASQ Certified Quality Engineer (CQE), Lean Six Sigma or similar certification.
• Familiarity with systems thinking principles and the ability to apply them to complex business processes.
• Working knowledge of relevant medical device regulations and standards, including the European Union Medical Device Regulation (EU MDR), ISO 13485 and ISO 14971.
• Exceptional attention to detail and a methodical…