Quality Engineer

Location: Malaysia | N/A

Department: Quality

Work Location: onsite

Key Responsibilities:

• Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements
• Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives
• Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis
• Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)
• Review and develop validation and test protocols; execute qualification and validation activities with proper documentation
• Participate in new product introductions, technology transfers, and evaluation of new equipment and processes
• Ensure compliance with Quality Management Systems (QMS) and applicable regulations (e.g., ISO13485, QSR)
• Collaborate cross-functionally with engineering, operations, suppliers, and customers to resolve quality-related issues
• Analyze operational and validation data to support decision-making and continuous improvement initiatives
• Provide technical guidance or mentorship to junior engineers, technicians, or inspectors where applicable
• Support internal and external audits and maintain effective quality system documentation

Requirements:

• Bachelor’s Degree in Science or Engineering
• 3 to 8 years of experience in manufacturing and operations quality
• Experience in the medical device industry is preferred
• Experience in people management is an advantage

Required Skills:

• Strong problem-solving skills with experience in root cause analysis and quality tools
• Good understanding of Quality Management Systems and regulatory standards (e.g., ISO13485, QSR)
• Experience handling nonconformance investigations and product risk assessments
• Ability to analyze data and make sound quality decisions
• Strong communication skills with ability to clearly present findings
• Ability to work effectively in a cross-functional manufacturing environment

About Us

As a global medical technology leader for more than 45 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.