Boston Scientific Supplier QA Engineer III 

United States, Minnesota, Maple Grove 

632297402

Spencer Gregory Hale

SQE III Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Your responsibilities will include:

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
• Develops and/or sources inspection tools and equipment.
• Assists in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Analyses incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.

What we're looking for in you:
Minimum qualifications:

• Bachelor’s degree in engineering, Computer Science or Related Field Desired.
• At least 2-3 years of experience in similar Quality Engineering role.
• Excellent written and verbal communication skills
• Demonstrated ability to identify and work with cross functional organizations to solve problems
• Strong command of MS Office – Word, Excel, PowerPoint.
• Ability to rapidly learn and use new applications

Preferred qualifications:

• Previous experience Supplier Quality, Quality, or Manufacturing background.
• Experience in the medical device industry
• Experience in working with or knowledge of manufacturing technologies associated with Plastics/Metal/Chemical/Extrusion or packaging type components/suppliers
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls
• Lead auditor certification ISO 13485 or previous auditing experience.
• Experience in problem solving and process improvement methodologies
• Process Validation, Risk Management, CAPA experience.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.