Boston Scientific is looking to solve health industry challenges by improving manufacturing floor processes and ensuring regulatory compliance
Requirements
- Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards
- Experience in Medical Device industry
- Experience on an automated/high-volume line
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
- Understanding of Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans
- Ability to apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Familiarity with PFMEA, risk reduction, and process change analysis
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
Other
- Pursuing a degree in Biomedical, Mechanical, Chemical, or Industrial & Systems Engineering
- Former Boston Scientific intern or co-op
- Ability to collaborate and influence across multiple, cross-functional teams
- Strong ability to successfully multi-task with adaptability
- Demonstrated effective change leadership and results-oriented focus
