Principal Supplier Quality Engineer

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. 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.   Department: Global QA Job Title: Principal Supplier Quality Engineer Location: Shanghai   Responsibilities: Supplier Manufacturing Process Evaluation:

Evaluates supplier manufacturing processes leveraging problem-solving methodologies in identifying, prioritizing, and resolving quality and down time issues. Perform detailed manufacturing work-station reviews for current, and potential, issues. Facilitates process improvements identified to minimize risks to product and production.  Reviews and approves supplier corrective action plans and verification of effectiveness (VoE) documentation. Tracks and presents VoE results to cross-functional teams and leadership. Facilitates DoE, Test Method Review, and Test Method Validation at vendors. Remediates material controls and traceability at vendors. Mentors local SQE’s on problem solving methodologies.

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.

Qualifications: Minimal qualifications:

Bilingual, fluency in Mandarin and English BS degree in engineering or related technical field with 6+ years of relevant experience. Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. Manufacturing/Manufacturing Quality experience; preferably supporting Injection Molding Experience remediating manufacturing process and traceability controls 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%.

10+ years of medical device engineering experience preferred. Extensive Injection Molding/Plastics experience Lead auditor of quality systems experience (ISO 13485 or similar). ASQ certification (CQE, CBA, SSGB, SSBB), or equivalent certification, strongly desired.

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