Senior Supplier Quality Engineer - SFMD

About the role

The Senior Supplier Quality Engineer – SFMD is a key member of the Sourced Finished Medical Device (SFMD) organization at Boston Scientific. This global, passionate team oversees a diverse network of suppliers that manufacture finished medical devices for distribution. The engineer demonstrates a primary commitment to patient safety and collaborates with cross‑functional internal and external resources to continually improve supplier manufacturing processes.

Evaluates and communicates quality issues to suppliers, applying systematic problem‑solving methodologies to identify, prioritize, and resolve issues. Reviews and approves supplier corrective action plans and verifies effectiveness documentation.

Proactively assesses supplier capabilities through on‑site visits and technical discussions, coordinating the evaluation of proposed changes at suppliers.

Plans and leads supplier audits to assess compliance with regulatory and company requirements, including audit scheduling, investigation, observation and findings evaluation, reporting, follow‑up, and confirmation of corrective actions.

Leads the execution of SFMD quality deliverables and collaborates with cross‑functional new product development teams to onboard finished medical device suppliers.

Generates and reviews quality plans, agreements, product specifications, component qualifications, design verification and validation, and process validations.

Collaborates with corporate and regional supplier quality organizations to develop policies, procedures, and guidelines, including their generation, review, and implementation.

Identifies and advises management on potential improvements to quality systems and processes.

Champions 100% compliance with company policies and SOPs.

• BS degree in engineering or a technical field with at least 5 years of relevant experience.
• Experience in the medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management skills, able to influence cross‑functional global 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 appropriately for the intended audience.
• Ability to rapidly learn and use new software applications, such as PLM and ERP.
• Domestic and international travel up to 25%.

• 7+ years of medical device engineering experience.
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.

Requisition

Minimum Salary: $85,000

Maximum Salary: $161,500

Actual compensation will vary based on location and other factors. Positions may include variable compensation, such as overtime, shift differential, annual bonus target, and long‑term incentives.

Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information, or any other protected class.

This role is deemed safety‑sensitive and requires a prohibited substance test as a condition of employment.