Senior Supplier Quality Engineer

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

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)

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.