Boston Scientific is looking for a Quality Engineer II to provide direct support to manufacturing within the Access and Delivery Solutions Assembly (ADSA) business unit, aiming to improve patients' lives and make a meaningful impact by developing, establishing, and maintaining quality engineering methodologies, systems, and practices in a dynamic production environment.
Requirements
- Demonstrated problem-solving & data analysis capabilities
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
- Strong understanding of Quality Systems
Responsibilities
- Direct production line support that includes presence in the manufacturing area and engagement with production operators
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Collaborate with technicians and manufacturing engineers in dispositioning non-conforming material, assisting in identification of manufacturing process defects, identification of primary root causes, and understanding corrective and preventative actions.
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Perform process validation and verification activities and generate/review related documentation
- Identifies possible sources of manufacturing defects and devises methods to reduce process variation to reduce/eliminate the cause of defects.
- Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints)
Other
- Bachelor's degree
- Minimum of 2 years of related work experience
- Experience in Medical Device industry
- Strong verbal, written communication skills, both technical and conversational
- Ability to collaborate and influence across multiple, cross-functional teams
