Quality Engineer I

The Quality Engineer I will collaborate with Quality Management to recommend, design, and implement functional process improvements across the manufacturing floor. Will work to develop, establish, and maintain Quality methodologies, systems, and practices which meet Boston Scientific, customer, and regulatory requirements.

The Quality Engineer I will perform Quality investigations and serve as a Quality representative for Data Analytics and Quality Metric reporting. Will provide partnership with cross-functional teams to deliver project support needed to integrate new product development.

* 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

* Prior Boston Scientific Quality Engineering intern experience

* 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

* 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