Global Production QA & Quality Management Leader

ROZER STERILIZER TECHNOLOGY (M) SDN. BHD.; Seberang Perai; On-site; MYR 70,000 - 110,000; Full time

Benefits offered by this job

13th month salary

Leave benefits

EPF, SOCSO, and EIS contributions

Corporate medical insurance

Overseas training opportunities

Dental Vision

Job summary

Rozer Sterilizer Technology (M) Sdn. Bhd. is expanding its Malaysia operations in Penang.

The Production Quality Assurance & Management Executive will oversee production quality, support QMS, and collaborate with cross-functional teams. You will monitor processes, conduct audits, investigate nonconformities, and maintain quality records to ensure ISO 13485 and GMP compliance. The role requires a bachelor’s degree and 2–4 years in quality assurance or medical device manufacturing; English,

Qualifications

• Bachelor’s degree in Quality Management, Biomedical Engineering, Science or related field.
• 2–4 years of quality assurance or production quality experience.
• Knowledge of ISO 13485, GMP and regulatory requirements for medical devices.
• Strong analytical, problem-solving and documentation skills.
• Good communication, English, Mandarin and Malay beneficial.

Responsibilities

• Monitor and control production quality processes including inspection and final release.
• Assist in implementing and maintaining ISO 13485 and GMP compliant QMS.
• Conduct routine production line audits and ensure SOP adherence.
• Investigate nonconformities and customer complaints; support CAPA.
• Collaborate with production, engineering and warehouse to improve processes.
• Maintain quality records and prepare management reports.
• Support internal and external quality audits and training staff.

Skills

Quality Assurance

ISO 13485

GMP

Documentation

Analytical

Multilingual

Education

Bachelor’s degree in Quality Management

Biomedical Engineering

Science

Job description

Rozer Sterilizer Technology (M) Sdn. Bhd. is expanding its Malaysia operations in Penang.

The Production Quality Assurance & Management Executive will oversee production quality, support QMS, and collaborate with cross-functional teams. You will monitor processes, conduct audits, investigate nonconformities, and maintain quality records to ensure ISO 13485 and GMP compliance. The role requires a bachelor’s degree and 2–4 years in quality assurance or medical device manufacturing; English,