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Boston Scientific Senior Engineer SFMD Supplier Quality 
China, Shanghai, Shanghai 
978733662

28.06.2024

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.

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