Global Production Quality Lead – Medical Device Sterilization

Rozer Sterilizer Technology; Seberang Perai; On-site; MYR 100,000 - 150,000; Full time

Job summary

A professional sterilization service provider in Penang is seeking a Production Quality Assurance & Management Executive. This role involves monitoring production quality processes, assisting in compliance with ISO 13485 and GMP standards, and maintaining quality records. Candidates should have a Bachelor's degree and 2–4 years of experience in quality assurance in the medical device industry. Proficiency in English, Mandarin, and Malay is an advantage, making it an exciting position in the growth of the Southeast Asian market.

Qualifications

• Minimum 2–4 years of quality assurance or production quality experience in the medical device or healthcare industry.
• Knowledge of ISO 13485, GMP, and regulatory requirements for medical devices.
• Proficiency in English, Mandarin, and Malay is an advantage.

Responsibilities

• Monitor and control production quality processes throughout production.
• Assist in compliance with quality management system standards.
• Conduct audits to ensure adherence to quality standards.
• Investigate nonconformities and implement corrective actions.
• Collaborate with teams to identify process improvement opportunities.
• Maintain quality records and prepare management reports.
• Support internal and external quality audits.
• Provide training on quality procedures to staff.

Skills

Analytical skills

Problem-solving skills

Communication skills

Interpersonal skills

Education

Bachelor’s degree in Quality Management, Biomedical Engineering, Science, or related field

Job description

A professional sterilization service provider in Penang is seeking a Production Quality Assurance & Management Executive. This role involves monitoring production quality processes, assisting in compliance with ISO 13485 and GMP standards, and maintaining quality records. Candidates should have a Bachelor's degree and 2–4 years of experience in quality assurance in the medical device industry. Proficiency in English, Mandarin, and Malay is an advantage, making it an exciting position in the growth of the Southeast Asian market.