Senior Quality Engineer, Global Post-Market

Boston Scientific; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Engineer - Global Post Market Support to establish and improve process controls for post-market complaint handling, ensuring compliance with FDA and global regulations. The role provides quality oversight to drive effectiveness, stability and continuous improvement across geographies.

You will lead cross-functional teams, apply SPC and systems thinking to improve processes, and collaborate with PM Surveillance, Risk Management and IT.

Qualifications

• Bachelor's degree in industrial engineering, statistics, sciences or related technical discipline.
• Minimum of 5 years' experience in a quality control-related role within a regulated industry (medical devices/pharma).
• Experience with statistical process control (SPC) and statistical tools for quality data analysis.
• Experience managing cross-functional projects in a regulated environment.

Responsibilities

• Establish robust process controls for complaint handling outputs to ensure alignment with customer requirements and reliable performance.
• Apply quality control expertise and SPC to drive continuous improvement of the complaint handling process.
• Evaluate end-to-end complaint handling process to identify dependencies, bottlenecks and potential failure modes; mitigate risk.
• Lead root cause investigations and implement effective CAPAs.
• Collaborate with Complaint Handling, Post-Market Surveillance, Risk Management, IT and Systems teams for compliance and effectiveness.
• Provide technical leadership to a team of global subject matter experts monitoring the process.
• Coordinate with global/divisional teams to maintain SOPs, work instructions and control plans for regulatory compliance.
• Collect, analyze and report key complaint handling outputs and trends to senior management.
• Translate customer needs into process requirements for outputs such as complaint codes.

Skills

Statistical Process Control (SPC)

Cross-functional collaboration

Education

Bachelor's degree in industrial engineering or statistics

Tools

CQE (certification)

EU MDR / ISO 13485 / ISO 14971 familiarity

Job description

Boston Scientific is seeking a Senior Quality Engineer - Global Post Market Support to establish and improve process controls for post-market complaint handling, ensuring compliance with FDA and global regulations. The role provides quality oversight to drive effectiveness, stability and continuous improvement across geographies.

You will lead cross-functional teams, apply SPC and systems thinking to improve processes, and collaborate with PM Surveillance, Risk Management and IT.