Quality Technician II
Cardiology DivisionAbout position:
The Quality Technician II directly supports new product development by establishing and maintaining quality methodologies, systems, and practices that meet BSC, customer, and regulatory requirements. Provides focused quality technical support within new product development to ensure the delivery of the highest quality product to the customer.Your responsibilities include:
Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements.
- Support Design Verification Activities: planning and execution
- Maintain inventory of product in support of Design Verification
- Coordinate sterilization, conditioning, and testing requests to internal and external vendors
- Primary contact for coordination of testing with Product Assurance Lab (write work requests, deliver product/accessories, maintain tested product)
- Participate in and follow direction with regard to basic statistical analysis
- Provide technical support to NPD teams as needed
- Assist engineers in failure analysis and CAPA activities
- Participate in continuous improvement projects
- Assist with product failure analysis
- Assist with audit-related activities
- Use documentation systems to research information and generate Change Notices
- Assist in developing and qualifying test methods, data sheets, test fixtures, and testing equipment
- Assist in the investigation of nonconforming materials, designs and/or systems
- Communicate with a wide variety of BSC personnel
Basic Qualifications:
- High School diploma and 2 years of experience in a technical environment in a regulated environment
- Comfortable with Microsoft Word and Excel computer software applications
- Good oral and written communication abilities
- Demonstrates good documentation practices and ability to maintain deadlines
Preferred Qualifications:
Medical device experience
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