Boston Scientific Supplier Quality Engineer 

China, Shanghai, Shanghai 

815039274

Responsibilities:

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.

Minimal qualifications:

• Bilingual, fluency in Mandarin and English
• BS degree in engineering or related technical field with 2+ 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:

• 3+ years of medical device engineering experience preferred.
• 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
• Experience in the medical device industry.
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
• Experience in problem solving and process improvement methodologies.
• Supplier Quality, Process Validation, Risk Management, CAPA experience.

Boston Scientific International Medical Trading (Shanghai) Co. Ltd. and its subsidiaries in the Chinese Mainland (hereinafter collectively referred to as “” or “
We”) fully respect your privacy rights, and we promise to process your personal information in a legitimated, appropriate, necessary and integrity principle:

1. We have taken industry-standard security measures to protect your personal information from unauthorized access, public disclosure, use, modification, damage or loss.
2. In order to protect your personal information rights and avoid unnecessary collection and export of personal information, youdo not need to expose the following information in the resume: ethnicity, home address, political opinion, education and work experience relevant to military, government and secret-related units.
3. In addition, as part of job application procedure, any personal information that you provided will be used (1) to process your application for a specific position (2) to process your application for other vacancies positions from all over the world that may be suitable for you, and we will keep your resume and interview related records in our systemfor 3 years. After the expiration of the storage period of your personal information, we will delete your personal information to make it inaccessible and keep relevant deletion records, except personal information that must be stored for a longer retention period in accordance with laws and administrative regulations.
4. As a multinational company conducting business globally, in order to improve the coordination and management of internal functions within the group and optimize human resource efficiency, we may need to share your personal information (as applicable) with Boston Scientific Corporation (our parent company) and other entities of Boston Scientific China outside the Chinese Mainland, as shown in the table below. In the event of international data transfers, we will take appropriate measures to protect your personal information, ensure compliance with legal and regulatory requirements, and ensure that the level of personal information protection by the overseas recipient meets or exceeds the requirements of China Data Protection Laws

• Overseas recipient:Boston Scientific Corporation
• Address:300 Boston Scientific Way, Marlborough, Massachusetts 01752, U.S.A. For other information related to Boston Scientific Corporation, you may refer to our official website:.
• Contact information/how to exercise your rights:You may exercise your rights using the following form:
• Processing carried out by the overseas recipient:collection, storage, view, deletion

1. If you have any questions about BSC personal information protection procedure, or need more information or want to raise further concerns, you can contact the Personal Information Protection Officer by writing to the Legal and Compliance Department of BSC ( address: at 31st Floor, Mengzi Road No.763, Huangpu District, Shanghai) or by email.