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Sr Supplier Quality Engineer, External Operations

Work mode:  Hybrid
Onsite Location(s): 

Shanghai, SH, CN

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

The Senior Supplier Quality Engineer will play an integral part in leading the performance improvement of Sourced Finished Medical Device (SFMD) suppliers to consistently meet Boston Scientific’s requirements. This individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with suppliers and cross-functional internal teams to ensure product quality meets expectations.

 

Your responsibilities include:

 

New Product Development:

  • Lead the execution of Quality deliverables for launch and collaborate with cross-functional team members to onboard finished medical device suppliers and innovative medical devices.
  • Review and assess project plans, agreements, product specifications, component qualifications, and process validations.
  • Assess readiness at supplier and support implementation of changes within quality system and manufacturing.
  • Provide technical oversight and project leadership during the development and implementation of capital equipment and single-use device manufacturing lines at external suppliers.

 

Sustaining Engineering:

  • Proactively assesses supplier capabilities through direct on-site visits and technical discussions.
  • Supports the evaluation of proposed changes at suppliers.
  • Communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation.
  • 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.
  • Lead supplier improvement initiatives at finished device vendors

 

Quality System Champion:

  • Collaborates with global and regional Supplier Quality organizations on policy, procedure, and guideline development.
  • Identifies and advises management on potential improvements to quality systems and processes.
  • Champions 100% compliance to company policies and SOP’s.

 

Minimal Qualifications:

  • BS degree in Engineering, Science, or related technical discipline
  • Minimum of 5 years of relevant experience.
  • Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • Experience in process validation, design controls, risk management, and CAPA.
  • Communicates effectively and concisely packages up information to deliver key points; appropriately scales communication style and depth according to the audience.
  • Ability to influence cross functional global teams spanning Quality, Design Assurance, R&D, Supplier Engineering, and Sourcing.
  • Ability to work independently and collaborate with project teams; organized and self-driven.
  • ISO 13485 lead auditor of quality systems experience. Working knowledge of FDA 21 CFR 820 and EU MDR.
  • English language proficiency.
  • Travel in China (Shanghai area) and occasional international travel. Total travel up to 50%.

 

Preferred Qualifications:

  • Background in Supplier Quality, Quality, or Operations
  • Experience working with Contract Manufacturers or OEM suppliers
  • Experience supporting Single-Use Device and Capital Equipment product lines
  • Proficient in MS Excel, Word, Project, PowerPoint, and ERP Systems

 

About us

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

Boston Scientific International Medical Trading (Shanghai) Co. Ltd. and its subsidiaries in the Chinese Mainland (hereinafter collectively referred to as “BSC” 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, you do 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 system for 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：
  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 globalprivacy@bsci.com.

For more information, please visit us at www.bostonscientific.com

 

 

Requisition ID: 608052

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


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