Global Supplier Quality Engineer – Medical Devices

Boston Scientific; Dorado (PR); On-site; USD 64,000 - 121,000; Full time

Job summary

Boston Scientific is seeking a QA Engineer to drive supplier quality, implement design controls and risk management, and lead cross-functional teams across Quality, Operations, R&D, and Sourcing. The role requires a BS in engineering and 5+ years in regulated industries, with a focus on improving supplier performance and supporting component qualification.

This is an on-site position based in Puerto Rico with comprehensive benefits.

Qualifications

• BS degree in engineering with at least 5 years in related field.
• Experience in medical devices or regulated industries.
• Cross-functional project management across Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA.
• Independent, organized and self-driven.
• Articulate communicator and able to scale information for audiences.
• Problem solving and project management experience.
• Experience managing supplier quality issues and SCAR ownership.
• Experience monitoring supplier performance and supplier process changes.
• Fully bilingual.

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.

Skills

Quality Assurance

Project Management

Supplier Quality

Process Validation

Design Controls

Risk Management

CAPA

Bilingual

Education

BS degree in engineering

Job description

Boston Scientific is seeking a QA Engineer to drive supplier quality, implement design controls and risk management, and lead cross-functional teams across Quality, Operations, R&D, and Sourcing. The role requires a BS in engineering and 5+ years in regulated industries, with a focus on improving supplier performance and supporting component qualification.

This is an on-site position based in Puerto Rico with comprehensive benefits.