- 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.
- 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.
- 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.
- 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%.
- 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
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Senior Engineer, SFMD Supplier Quality - Shanghai, 中国 - Boston Scientific
描述
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 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:
New Product Development:
Quality System Champion:
What we're looking for in you:
Minimal qualifications:
Preferred qualifications:
Requisition ID: 580530
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
