Senior Quality Leader – Medical Devices & Compliance

Boston Scientific; George Town; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading global medical technology company is seeking a Quality Engineering Manager in George Town, Malaysia. The role focuses on developing a high-performance quality engineering team, ensuring compliance with quality standards, and leading initiatives to enhance the quality management system. Candidates should possess a degree in Biomedical Science or an equivalent engineering field, along with significant managerial experience in the medical industry. This is an opportunity to make a meaningful impact on patient health and safety.

Qualifications

• Minimum 10 years of experience working in a managerial capacity within a production environment in the medical industry.
• Well versed in ISO 13485 and 21 CFR 820 requirements.
• Minimum 3 years of experience managing engineers and technicians.

Responsibilities

• Develops and manages a high-performance quality engineering team focused on customer needs and compliance.
• Has independent authority to make decisions related to product quality.
• Develops and directs plans for major segments of complex projects from a quality perspective.

Skills

People management skills

Problem solving skills

Risk Management skills

Excursion handling skills

Statistics

Understanding of Finance 101

Education

Minimum Degree in Biomedical Science, Science or equivalent Engineering field

Job description

A leading global medical technology company is seeking a Quality Engineering Manager in George Town, Malaysia. The role focuses on developing a high-performance quality engineering team, ensuring compliance with quality standards, and leading initiatives to enhance the quality management system. Candidates should possess a degree in Biomedical Science or an equivalent engineering field, along with significant managerial experience in the medical industry. This is an opportunity to make a meaningful impact on patient health and safety.