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Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks a Supplier Quality Engineer to drive supplier quality improvements and ensure component conformity for medical devices. You will assess suppliers, define acceptance criteria and support corrective actions.
The role emphasizes collaboration with suppliers, data-driven problem solving, and oversight of supplier performance within a regulated manufacturing environment.
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.
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 2~5 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.
Hirer responsiveness Salary match Number of applicants
Your application will include the following questions:
Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees
Your work can make a difference.
Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.
For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies
And Penang is part of that global story.
Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.
Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.
Your work can make a difference.
Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.
For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies
And Penang is part of that global story.
Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.
Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.
What can I earn as a Supplier Quality Engineer