Quality Technician

Boston Scientific; Malaysia; On-site; MYR 50,000 - 80,000; Full time

Job summary

Boston Scientific is looking for a Quality Assurance professional in Malaysia. You will be responsible for conducting tests, maintaining documentation, and monitoring compliance with regulatory standards.

The ideal candidate has a diploma in Science or Engineering along with 3-8 years of experience, preferably in the medical device industry. Strong analytical skills, attention to detail, and communication proficiency are essential.

Qualifications

• Minimum 3 years of experience in a manufacturing environment, preferably in quality or operations.
• Experience in medical device or regulated industry is preferred.

Responsibilities

• Perform final functional testing and product inspections.
• Review, update, and maintain QA documentation.
• Initiate and ensure closure of nonconformance reports.
• Conduct product defect analysis and support CAPA.
• Monitor and report quality issues with data.
• Compile reporting activities and Non-Conformance Board reports.
• Collaborate to resolve manufacturing and quality issues.
• Ensure compliance with QA standards and regulatory guidelines.
• Identify opportunities for continuous improvement.
• Escalate concerns related to EHS or quality risks.
• Guide junior team members and contribute to process improvements.

Skills

Quality mindset

Analytical skills

Problem-solving skills

Communication skills

Experience in final testing

Familiarity with MES/SAP

Understanding of ISO 13485

Adaptability

Education

Minimum Diploma in Science, Engineering, or related field

Tools

Manufacturing systems (e.g., MES, SAP)

Job description

Key Responsibilities

• Perform final functional testing, product/material release inspections, and record test results accurately
• Review, update, and maintain Quality Assurance (QA) documentation
• Initiate, investigate, and ensure timely closure of nonconformance reports
• Conduct product defect analysis and support root cause investigation and corrective/preventive actions (CAPA)
• Monitor and report quality issues using data from testing, inspections, and process monitoring
• Compile and support reporting activities, including Non-Conformance Board reports and ad hoc management reports
• Collaborate with Quality Engineering and Operations teams to resolve manufacturing and quality issues
• Ensure compliance with QA laboratory procedures, plant-wide processes, and regulatory standards
• Identify opportunities for continuous improvement in product quality and process efficiency
• Escalate concerns related to environment, health, safety (EHS), or quality risks
• For experienced candidates, provide guidance to junior team members and contribute to process improvements

Requirements

• Minimum Diploma in Science, Engineering, or related field
• 3–8 years of experience in a manufacturing environment, preferably in quality or operations
• Experience in medical device or regulated industry is preferred

Skills & Competencies

• Strong quality mindset with high attention to detail
• Good analytical and problem-solving skills
• Ability to work independently and collaborate effectively within cross-functional teams
• Good written and verbal communication skills in English
• Experience in final functional testing and inspection processes
• Familiarity with manufacturing systems (e.g., MES, SAP)
• Basic understanding of ISO 13485, QMSR, or equivalent quality regulations
• Adaptable, proactive, and able to manage priorities in a fast-paced environment