Supplier Quality Engineer II – Medical Devices

Boston Scientific; Marlboro (MA); On-site; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific’s SFMD Supplier Quality Engineering team seeks a qualified engineer to collaborate with suppliers and internal teams to ensure patient safety and product quality. The role focuses on sustaining engineering, new product development, and championing quality systems across the supplier network.

Responsibilities include leading supplier audits, CAPA, and data-driven quality improvements, with up to 25% travel.

Qualifications

• BS degree in engineering or technical field.
• 2+ years of quality engineering experience within med device (or 3+ years in a different regulated industry).
• Experience in medical device, automotive, aeronautical, or other regulated industry.
• Ability to communicate effectively, and concisely package information to deliver key points.
• Ability to work independently; organized and self-driven.
• Ability to rapidly learn and use new software applications (e.g., ERP, PLM).
• Domestic and international travel up to 25%.

Responsibilities

• Sustaining Engineering: identify and communicate quality issues to suppliers and apply problem-solving methodologies; review supplier corrective action plans and verification of effectiveness documentation.
• Assess supplier capabilities through on-site visits and technical discussions; evaluate proposed changes at suppliers.
• Plan and lead supplier audits to ensure regulatory and Boston Scientific requirements; follow-up on observations and actions.
• Tracks and trends supplier performance and provides quality data for management reviews and complaint reviews.
• New Product Development: support SFMD quality deliverables and onboard finished medical device suppliers and innovative devices; generate/review quality plans and product specifications.
• Quality System Champion: collaborate on policy, procedure, and guideline development; identify improvements to quality systems; ensure 100% compliance to policies and SOPs.

Skills

Quality engineering

Regulated industry

Auditing

Travel 25%

Education

BS degree in engineering

Tools

ERP

PLM

Job description

Boston Scientific’s SFMD Supplier Quality Engineering team seeks a qualified engineer to collaborate with suppliers and internal teams to ensure patient safety and product quality. The role focuses on sustaining engineering, new product development, and championing quality systems across the supplier network.

Responsibilities include leading supplier audits, CAPA, and data-driven quality improvements, with up to 25% travel.