Boston Scientific Supplier QA Eng - P1 

Ireland, Cork 

475519622

Advancing possibilities for a brighter tomorrow

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.

Responsibilities:

• 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.
• May supervise inspectors.

Qualifications:

• NFQ Level 8 or above in Science or Engineering Discipline
• 2/3 years’ experience in the medical device industry with direct experience in a QA environment (preferably GMP regulated)
• Previous experience in Supplier Quality an advantage
• Organized and detail-oriented; ability to prioritize and manage multiple projects
• Strong interpersonal skills with ability to develop internal and external relationships
• Lead auditor certification ISO 13485 or previous auditing experience an advantage

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