Senior Supplier Quality Engineer – Elevate Device Quality

Boston Scientific; Arden Hills (MN); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Supplier Quality Engineer for the SFMD organization in Arden Hills, MN. You will oversee a global supplier network, drive quality improvements, and lead audits to ensure compliance with regulatory requirements.

The role focuses on sustaining engineering, new product development, and quality system improvements to safeguard patient safety. The ideal candidate has a BS in engineering with extensive experience in regulated industries, strong project management,

Qualifications

• BS degree in engineering or technical field with 5 years relevant experience.
• Experience in the medical device or a regulated industry.
• Project management to influence cross-functional teams spanning quality, operations, R&D, and sourcing.
• Experience in process validation, design controls, risk management, and CAPA.
• Ability to work independently; organized and self-driven.
• Articulate communicator; adept at packaging and scaling information for the audience.
• Ability to rapidly learn and use new software (PLM, ERP).
• Domestic and international travel up to 25%.

Responsibilities

• Sustaining Engineering: evaluates and communicates quality issues to suppliers and applies problem-solving methods to identify, prioritize, and resolve quality issues.
• Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through on-site visits and technical discussions.
• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements.
• New Product Development: lead the execution of SFMD quality deliverables and onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validation, and process validations.
• Quality System Champion: collaborates on policy, procedure, and guideline development; ensures 100% SOP compliance.

Skills

Project management

Process validation

Design controls

Risk management

CAPA

Cross-functional collaboration

Communication skills

PLM/ERP

Travel willingness

Education

BS in Engineering

Tools

Auditing (lead)

ISO 13485

Job description

Boston Scientific is seeking a Senior Supplier Quality Engineer for the SFMD organization in Arden Hills, MN. You will oversee a global supplier network, drive quality improvements, and lead audits to ensure compliance with regulatory requirements.

The role focuses on sustaining engineering, new product development, and quality system improvements to safeguard patient safety. The ideal candidate has a BS in engineering with extensive experience in regulated industries, strong project management,