Quality Engineer I

Summary

Boston Scientific is a global medical technology leader that develops innovative devices and therapies to improve patient care across multiple disease areas. The Quality Engineer I will collaborate with Quality Management and cross-functional teams to improve manufacturing processes, maintain quality systems, and support regulatory compliance. The role will also conduct quality investigations, analyze quality metrics, and support new product development and production improvement projects.

Responsibilities

• Identify Manufacturing signals (OOS and scrap) by dispositioning non-conforming material, assisting in identification of primary root causes, and understanding corrective and preventative actions
• Lead investigations to determine products affected by Non-Conformance issues, Hold Notices (Quality Notifications), Product Inquiry Reports, and Field Action data
• Quality support on value stream and quality process improvement projects
• Identify, support, and lead quality projects to support production unit area strategy
• Ensure Regulatory compliance in day-to-day responsibility by utilizing quality tools and processes (PFMEA, risk reduction, process change analysis)
• Support Preventive Quality initiatives in value stream; drive & participate in Workstation Vulnerability Assessments program to support the Production Area Strategy
• Provide training and guidance to the Quality Technicians on internal policies and procedures
• Ensure that corrective and preventive measures meet acceptable reliability standards
• Gain understanding of Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans
• Support the evaluation of the adequacy and compliance of systems, operations, and practices against regulation and company documentation
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• May be responsible for audit preparation and audit activities

Skills

• Previous Boston Scientific Quality Engineering internship experience
• Have to obtain a Bachelors degree in Biomedical or Industrial & Systems Engineering by spring 2027
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task with adaptability
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards
• Experience in Medical Device industry
• Experience on an automated/high-volume line
• Comfort speaking to groups of individuals including divisional senior leaders; presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences
• Demonstrated effective change leadership and results-oriented focus
• Demonstrated problem-solving & data analysis capabilities

Qualifications

Must Haves

• Previous Boston Scientific Quality Engineering internship experience
• Have to obtain a Bachelors degree in Biomedical or Industrial & Systems Engineering by spring 2027

Nice to Haves

• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task with adaptability
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards
• Experience in Medical Device industry
• Experience on an automated/high-volume line
• Comfort speaking to groups of individuals including divisional senior leaders; presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences
• Demonstrated effective change leadership and results-oriented focus
• Demonstrated problem-solving & data analysis capabilities

Benefits

• Access to the latest tools, information and training to advance skills and career
• Support in progressing, whatever your ambitions
• Relocation and housing assistance may be available to those who meet the eligibility criteria
• Variable compensation from time to time for non-exempt (hourly), non-sales roles, including overtime and shift differential, subject to eligibility and requirements
• Annual bonus target for non-exempt (hourly), non-sales roles, subject to plan eligibility and other requirements
• Annual bonus target and long-term incentives for exempt, non-sales roles, subject to plan eligibility and other requirements