Senior Quality Engineer - Global Post Market Support

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. This recognition is complemented by our broader workplace culture: 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.

We are seeking a Senior Quality Engineer to support our global post-market complaint handling processes. In this role you will establish, maintain and continuously improve process controls that help ensure the reliability of post-market complaint handling outputs. You will provide quality oversight to support compliance with FDA and other global regulatory

while advancing process effectiveness, stability and continuous improvement.

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

for critical outputs, such as complaint codes, ensuring downstream users have reliable information for analysis and decision-making.

• ✓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.

• ✓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 approach to data analysis.
• ✓Excellent problem-solving, influencing and critical-thinking skills.
• ✓Excellent written and verbal communication skills, including the ability to present complex data to diverse audiences.
• ✓Demonstrated ability to collaborate effectively with cross-functional teams.
• ✓Proactive and accountable mindset with a focus on delivering solutions.

Maximum Salary: $ 161500

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