Senior Supplier Quality Assurance Engineer

Boston Scientific; California; Presencial; USD 64 000 - 121 000; Tempo integral

Resumo da oferta

Boston Scientific is seeking a Sr. Supplier QA Engineer to drive quality improvements for outside-sourced components. The role supports supplier selection, inspection procedures, and test protocol development, with emphasis on CAPA and supplier performance management.

Requires a BS in engineering with 5+ years in medical devices or regulated industries, strong project management, and ASQ CQE preferred. Role may involve supervision of inspectors and cross-functional teamwork.

Qualificações

• BS degree in engineering with 5+ years of related experience or equivalent.
• Experience in medical devices or other regulated industry.
• Project management: influence cross functional global teams across 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; able to package information for the audience.
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.
• 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.

Responsabilidades

• 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.
• 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.

Conhecimentos

Project management

Process validation

Design controls

Risk management

CAPA

Communication

Problem solving

ASQ CQE

Supplier quality

Supplier performance

Component qualification

Self-motivated

Bilingual

Formação académica

BS degree in engineering

Descrição da oferta de emprego

Boston Scientific is seeking a Sr. Supplier QA Engineer to drive quality improvements for outside-sourced components. The role supports supplier selection, inspection procedures, and test protocol development, with emphasis on CAPA and supplier performance management.

Requires a BS in engineering with 5+ years in medical devices or regulated industries, strong project management, and ASQ CQE preferred. Role may involve supervision of inspectors and cross-functional teamwork.