Senior Supplier QA Engineer

Boston Scientific Corporation; Penang; Remote; MYR 180,000 - 260,000; Full time

Job summary

Boston Scientific Corporation in Penang, Malaysia seeks a seasoned Supplier Quality Engineer (SQE) to join the Global Quality Service Supplier (GQSS) team. You will lead supplier quality initiatives across calibration, labs, and service providers, drive SCARs, and mentor vendors to meet BSC quality standards.

The role requires a BS in Engineering, 7+ years in QA within manufacturing or service environments, and experience with ISO 9001/13485.

Qualifications

• 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.
• 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.

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.

Skills

Mandarin communication

Root Cause Investigation

Vendor management

Quality system knowledge

Education

Bachelor of Science in Engineering/Technology

Job description

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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.

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.


• 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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QA, Quality Assurance, Logistics, QA Engineer, Medical Device Engineer, Quality, Technology, Operations, Engineering