Senior Quality Engineer - Post-Market CAPA & Process Lead

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is 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 requirements while advancing process effectiveness, stability and continuous improvement.

Qualifications

• 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) or Lean Six Sigma or similar certification (preferred).
• Familiarity with EU MDR, ISO 13485 and ISO 14971 (preferred).
• Excellent written and verbal communication skills, and ability to present complex data to diverse audiences.
• Demonstrated ability to collaborate with cross-functional teams.

Responsibilities

• 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 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 SOPs, work instructions and control plans for compliance.
• 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.

Education

Bachelor's degree in Industrial Engineering or related field

Job description

Boston Scientific is 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 requirements while advancing process effectiveness, stability and continuous improvement.