Global Supplier QA Engineer II with Quality Impact

Boston Scientific Gruppe; Dorado (PR); On-site; USD 52,300 - 99,400; Full time

Job summary

Boston Scientific is seeking a Supplier QA Engineer II to drive improvements in the quality of externally sourced components. You will assess suppliers, develop inspection procedures, and support design and qualification activities to ensure robust component quality.

Responsibilities include supplier evaluation, testing protocols, corrective actions, and collaboration with Quality, Operations, R&D, and Sourcing to resolve issues and ensure regulatory compliance.

Qualifications

• BS degree in engineering with a minimum of 3 years of related experience or an equivalent combination of education and work experience.
• Experience in medical devices or other regulated industry.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA.
• Ability to work independently; organized and self-driven.
• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
• Problem Solving and Project Management experience
• Experience managing supplier quality issues, including supplier nonconformance escalation and SCAR ownership.
• Experience monitoring supplier performance and supporting continuous improvement activities.
• Experience supporting component qualification and supplier process changes.
• Fully Bilingual

Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Generates and maintains incoming inspection 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; communicates issues to suppliers.
• Reviews new design specifications from a quality perspective.

Skills

Project management

Communication

Problem solving

Supplier quality management

Cross-functional collaboration

Bilingual

Independent/self-driven

Education

BS degree in engineering

Job description

Boston Scientific is seeking a Supplier QA Engineer II to drive improvements in the quality of externally sourced components. You will assess suppliers, develop inspection procedures, and support design and qualification activities to ensure robust component quality.

Responsibilities include supplier evaluation, testing protocols, corrective actions, and collaboration with Quality, Operations, R&D, and Sourcing to resolve issues and ensure regulatory compliance.