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Boston Scientific

Senior Supplier QA Engineer

Boston Scientific George Town, Penang, Malaysia

Medical Equipment Manufacturing · 10,001+ employees

Yesterday
qa Senior (5-10 yrs) Full-time Malaysia
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About the role

The Senior Supplier QA Engineer will lead supplier selection, monitoring, and technical support while ensuring compliance with quality system requirements. They are responsible for managing supplier corrective actions, conducting audits, and collaborating with cross-functional teams to resolve quality issues.

What they look for

Supplier Quality Engineering ISO 13485 ISO 9001 Root Cause Investigation CAPA Supplier Audits Quality Assurance Medical Device Industry Vendor Management Corrective Action Requests Process Improvement Technical Support Communication Skills Mandarin Language

Requirements

Candidates must hold a Bachelor of Science degree in Engineering or a related field and possess at least 7 years of experience in manufacturing or quality assurance. Proficiency in ISO 13485, root cause analysis, and the ability to communicate in Mandarin are required for this role.

Full description

Purpose Statement

The Supplier Quality Engineer (SQE) P4 is part of the Global Quality Service Supplier (GQSS) team and focused on all aspects of supplier selection, supplier process and technical support for Boston Scientific. The GQSS team is responsible for technical leadership, supplier monitoring and resolution of non-conformances within the service supplier supply chain (Sterilization, Calibration, Labs, 3PL, Non-Device software etc.).

Job responsibilities

  • Represents Quality on teams comprising of representatives from Purchasing, Supplier Quality, Supplier Engineering, R&D and Business Units.
  • Demonstrates skills in vendor relationships, vendor requirements for Commodity and Category Management.
  • Supports investigation of Quality issues. Works with Quality, Procurement & Business Units to resolve issues.
  • Educates vendors on the Boston Scientific (BSC) Quality System requirements.
  • Works with Procurement, Global Sourcing, BSC Departments (such as calibration, Labeling, Warehousing/Logistics, Labs) & Business Units/Project Teams to ensure that service suppliers meet established requirements.
  • Ensure that Supplier Corrective Actions Requests (SCAR's) are identified, implemented and completed.
  • Provides guidance to BSC departments in applying BSC Supplier Mgmt. requirements.
  • Owns Service Related CAPA's and/or participates in a CAPA Team.
  • Contributes to the development, maintenance and improvement of Supplier Management Policies and Procedures.
  • Leads Service Supplier Audits.

Job Requirements:

  • Bachelor of Science Degree in Engineering/Technology or related degree
  • 7+ years' experience in a manufacturing or service provider environment or equivalent with direct experience in a quality assurance environment.
  • Good communication/presentation skills
  • Medical device industry experience
  • Knowledge of ISO 9001 & ISO 13485 and experience leading audits to these standards
  • Working knowledge of Root Cause Investigation processes and tools.
  • Ability to travel up to 25% (domestic and international)
  • Ability to communicate in Mandarin to support business engagements with China-based vendors.

About Us As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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