Supplier Quality Engineer II - External Ops (Hybrid)

Boston Scientific; Marlborough (MA); Hybrid; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific’s External Operations organization seeks a Supplier Quality Engineer II to oversee supplier quality for SFMD products, including single-use devices and capital equipment. The role is based in Marlborough, MA with a hybrid schedule and 3 onsite minimum days, reporting to the Marlborough site.

Responsibilities include leading supplier audits, coordinating CAPA and change actions, and collaborating with cross-functional teams to uphold regulatory standards and quality systems.

Qualifications

• BS degree in engineering; 1+ years in supplier interaction, quality systems, or regulated processes.
• Experience in regulated industries (medical device, automotive, etc.).
• Ability to influence cross-functional global teams (Quality, Operations, R&D, Sourcing).
• Experience with process validation, design controls, risk management, CAPA, SCAR.
• Willingness to travel up to 25%.

Responsibilities

• Evaluates and communicates quality issues to suppliers and applies problem-solving methodologies.
• Proactively assesses supplier capabilities through on-site visits and discussions.
• Plans and leads supplier audits for regulatory compliance and internal requirements.
• Manages sustaining quality issues, change impacts, and design changes for suppliers.
• Investigates non-conformances from incoming inspection at distribution centers.
• Supports Design Quality Assurance with post-market signals and product inquiries.
• Investigates complaints and manages NCEPs at OEM/CM suppliers and other suppliers.

Skills

Supplier QA

Project management

Process validation

CAPA

Auditing

Education

BS in Engineering

Tools

PLM

ERP

Job description

Boston Scientific’s External Operations organization seeks a Supplier Quality Engineer II to oversee supplier quality for SFMD products, including single-use devices and capital equipment. The role is based in Marlborough, MA with a hybrid schedule and 3 onsite minimum days, reporting to the Marlborough site.

Responsibilities include leading supplier audits, coordinating CAPA and change actions, and collaborating with cross-functional teams to uphold regulatory standards and quality systems.