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Boston Scientific · 4 months ago

Quality Engineer I

Maple Grove US-MN, United States | N/A

Full-time

Onsite

New Grad, Entry Level

$58K/yr - $110K/yr

Boston Scientific is a leader in medical science committed to solving health industry challenges. The Quality Engineer I role involves collaborating with Quality Management to implement process improvements and ensure compliance with quality standards while supporting cross-functional teams in new product development.

Health CareMedicalMedical Device

No H1B

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

Qualification

Quality System RegulationsISO13485 Quality StandardsData AnalysisBiomedical EngineeringMechanical EngineeringProblem-SolvingPresentation SkillsMicrosoft OfficeChange LeadershipCollaborationAdaptability

Required

Former Boston Scientific intern or co-op

Pursuing a degree in Biomedical, Mechanical, Chemical, or Industrial & Systems Engineering

Preferred

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