Production Quality Assurance & Management Executive

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

Production Quality Assurance & Management Executive

Rozer Sterilizer Technology is a professional third-party provider of ethylene oxide (EO) sterilization services, established in 2014. Headquarter in Changshu, China. Rozer serves global medical device manufacturers and has been registered with both the U.S. FDA and the Japan Ministry of Health, with certifications from TÜV SÜD.

With years of expertise and a strong commitment to quality, Rozer has built state-of-the-art sterilization facilities and is expanding operations to Malaysia. Our new Malaysian plant will serve as astrategic hub for Southeast Asia, offering world-class sterilization capacity, strict compliance with GMP standards, and reliable supply chain support.

At Rozer, we value integrity, innovation, and excellence. Join us to be part of a company that safeguards global healthcare through sterilization technology.

Learn more at http://www.rozer.net/page/html/about.php

Job Responsibilities:

Monitor and control production quality processes, including raw material inspection, in-process quality checks, and final product release.

Assist in the implementation, documentation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and GMP.

Conduct routine production line audits to ensure adherence to SOPs and quality standards.

Investigate nonconformities and customer complaints, support root cause analysis, and implement corrective and preventive actions (CAPA).

Collaborate with production, engineering, and warehouse teams to identify process improvement opportunities.

Maintain accurate and up-to-date quality records and prepare reports for management review.

Support internal and external quality audits, including customer and certification body audits.

Provide training and guidance to production staff on quality procedures and standards.

Requirements:

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

Minimum 2–4 years of quality assurance or production quality experience, preferably in the medical device or healthcare manufacturing industry.

Knowledge of ISO 13485, GMP, and regulatory requirements for medical devices.

Strong analytical, problem-solving, and documentation skills.

Good communication and interpersonal skills; proficiency in English, Mandarin, and Malay will be an advantage.

Perks and benefits

• 13th month salary (year-end bonus)
• Leave Benefits
• EPF, SOCSO, and EIS contributions
• Corporate Medical Insurance
• Opportunities to participate in overseas training
• Dental Vision