Senior Process Development Engineer

Boston Scientific; Penang; On-site; MYR 90,000 - 150,000; Full time

Job summary

Boston Scientific in Malaysia is seeking a Senior Supplier Quality Engineer to ensure external components meet stringent quality standards. You will collaborate with suppliers, lead CAPA activities and drive corrective actions to prevent field failures, with a focus on supplier quality systems and continuous improvement.

The role requires a Bachelor's degree in Engineering and at least eight years' experience in supplier quality management, statistical analysis, and cross-functional teamwork to

Qualifications

• Bachelor’s Degree in Engineering or a related technical discipline.
• Eight years of working experience in supplier quality or related field.
• Proven experience in supplier quality management.
• Ability to collaborate with suppliers to ensure quality standards.
• Strong problem-solving with a data-driven approach.

Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Generate and maintain incoming inspection procedures.
• Develop inspection tools and equipment.
• Assist in generating component specifications.
• Generate test protocols and qualification reports for components.
• Provide input to Design Engineering on new component technology.
• Analyze incoming material defects and drive corrective actions.
• Review design specs for manufacturability and quality.
• Investigate field failures related to supplier materials and implement corrective actions.
• May supervise inspectors.

Skills

Supplier quality management

Problem solving

Data-driven decision making

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

SCAR system

CAPA tools

Job description

Purpose Statement

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Purpose Statement

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Key Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
• Develops and/or sources inspection tools and equipment.
• Assists in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Analyses incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.
• May supervise inspectors.

Job Requirements

• Candidate required process at least Bachelor’s Degree in Engineering or a related technical discipline (e.g., Mechanical, Manufacturing, Materials, Industrial, Chemical, or Biomedical Engineering).
• At least 8 years of working experience in related field.
• Proven experience in supplier quality-related functions, with a strong track record in supplier quality management.
• Demonstrated ability to work collaboratively with suppliers to ensure compliance with quality standards and drive continuous improvement.
• Excellent problem-solving skills with a structured and data-driven approach.

Technical & Functional Competencies

• Supplier Quality Systems Expertise: Strong working knowledge of supplier compliance, change control, Supplier Corrective Action Requests (SCAR), risk management, and material controls within a regulated manufacturing environment.
• Problem Solving & Statistical Analysis: Proficiency in structured problem-solving methodologies and statistical analysis tools to identify root causes and implement effective corrective actions.

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.