Senior Supplier QA Engineer — Medical Devices

Boston Scientific; United States; On-site; USD 64,000 - 121,000; Full time

Job summary

Boston Scientific is seeking a Sr. Supplier QA Engineer to drive supplier quality improvements for external components and support supplier qualification activities.

The role requires a BS in engineering with 5+ years in medical devices or a regulated industry, plus strong CAPA, design controls and risk management experience. You will lead cross-functional teams spanning Quality, Operations, R&D and Sourcing, and mentor inspectors as needed.

Qualifications

• BS degree in engineering with a minimum of 5 years of related experience.
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.
• 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.

Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Provide technical support for the introduction of components from a new supplier.
• Generate and maintain incoming inspection procedures; train inspectors.
• Develops inspection tools and equipment; assist in generating component specifications.
• Generate test protocols, monitor testing, and approve components for use in products.
• Provide input to Design Engineering on component technology and selection with quality and reliability analysis.
• Analyze incoming material defects; disposition and drive corrective action; communicate issues to suppliers.
• Review new design specifications from a component quality and manufacturability perspective.
• Investigate field failures related to supplier materials and develop corrective actions.
• May supervise inspectors.

Skills

Project management

CAPA

Process validation

Design controls

Risk management

Communication

Education

BS degree in engineering

ASQ certification (CQE/CBA/SSGB/SSBB) desired

Job description

Boston Scientific is seeking a Sr. Supplier QA Engineer to drive supplier quality improvements for external components and support supplier qualification activities.

The role requires a BS in engineering with 5+ years in medical devices or a regulated industry, plus strong CAPA, design controls and risk management experience. You will lead cross-functional teams spanning Quality, Operations, R&D and Sourcing, and mentor inspectors as needed.