Senior SQE: Lead Medical Device Supplier Quality

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Batu Kawan; On-site; MYR 180,000 - 260,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking a Supplier Quality Engineer (SQE) P4 to join the Global Quality Service Supplier (GQSS) team in Penang.

The role focuses on supplier selection, process control and technical support across sterilization, calibration, labs and 3PL services, with quality system compliance and CAPA ownership. The successful candidate will lead supplier audits, drive SCARs, mentor vendors on BSC requirements, and collaborate with Purchasing, Supplier

Qualifications

• 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.

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

Supplier Quality

Quality Assurance

Audits ISO 9001/13485

Root Cause Analysis

Vendor Management

Education

Bachelor of Science in Engineering/Technology

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking a Supplier Quality Engineer (SQE) P4 to join the Global Quality Service Supplier (GQSS) team in Penang.

The role focuses on supplier selection, process control and technical support across sterilization, calibration, labs and 3PL services, with quality system compliance and CAPA ownership. The successful candidate will lead supplier audits, drive SCARs, mentor vendors on BSC requirements, and collaborate with Purchasing, Supplier