Quality Engineer I

Boston Scientific•,

10h•Onsite

About The Position

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. At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be in our local office at least five days per week. Relocation and housing assistance may be available to those who meet the eligibility criteria. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time We will consider qualified applicants of all ages who are starting (or restarting) their careers As a Quality Engineer 1, you will collaborate with Quality Management to recommend, design, and implement functional process improvements across the manufacturing floor. You will work to develop, establish, and maintain Quality methodologies, systems, and practices which meet Boston Scientific, customer, and regulatory requirements. As a Quality Engineer 1, you will perform Quality investigations and serve as a Quality representative for Data Analytics and Quality Metric reporting. You will provide partnership with cross-functional teams to deliver project support needed to integrate new product development.

Requirements

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

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