About the role:

The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our contract manufacturer and OEM supplier’s manufacturing processes.


Your responsibilities will include:

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.

• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.

• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.

New Product Development:

• Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.

• Generate and review quality plans, agreements, product specifications, component qualifications, and process validations.

Quality System Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.

• Identifies and advises management on potential improvements to quality systems and processes in the company.

• Champions 100% compliance to company policies and SOP’s.
What we’re looking for in you:

Minimal qualifications:

• Bilingual, fluency in Mandarin and English

• BS degree in engineering or related technical field with 4+ years of relevant experience.

• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.

• Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.

• Relationship building: ability to collaborate and build strong relationships with suppliers

• Experience in process validation, design controls, risk management, and CAPA.

• Ability to work independently; organized and self-driven.

• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.

• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).

• Domestic and international travel up to 20%.

Preferred qualifications:

• 7+ years of medical device engineering experience preferred.

• 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.

• Medical Device OEM Supplier Quality Management is a plus

其他信息
语言要求：英语、普通话