Boston Scientific Senior Supplier Quality Engineer 

Malaysia, Penang 

160230472

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

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

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

Key Qualifications

• Fluency in English
• BS degree in engineering or related technical field with 4+ years ofrelevant experience in the medical device industry
• Project management experience: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing
• Relationship building focused: 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 is preferred
• Experience in the automotive, aeronautical, semiconductor, or other regulated industry
• 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