Shuyou Industrial Malaysia Sdn. Bhd. Hiring! Full Time Assistant Quality Management Manager in Pulau Pinang, Earn up to MYR 7,800 - Ricebowl

Qualifications & Requirements

• Proficiency in both spoken and written Mandarin is preferred.
• Bachelor’s degree or above in Biomedical Engineering, Pharmacy, Laboratory Science, Polymer/Textile Materials, Industrial Engineering, or a related field.
• At least 5 years of quality management experience in medical device manufacturing, or 3 years of team management experience covering QA, QC, and Quality Management Systems (QMS).
• ISO 13485:2016 Internal Auditor Certification is required.
• Familiar with ISO 14971 Risk Management, ISO 11135/ISO 11137 sterilization validation, and Sterile Barrier System (SBS) validation is preferred.
• Familiar with ISO 13485:2016 and basic requirements of FDA 21 CFR Part 820 (QSR) and EU MDR 2017/745 is preferred.

Key Responsibilities

• Manage the overall quality control process, including IQC, IPQC, OQC, and batch release.
• Oversee quality control of cleanrooms (ISO Class 7/8), including temperature, humidity, and microbiological monitoring.
• Ensure factory facility compliance and manage routine ethylene oxide (EO) residual testing.
• Manage process validation activities, including IQ, OQ, PQ, SPC, MSA, FMEA, and Control Plans.
• Develop and implement the annual validation plan and ensure timely execution.
• Develop and manage internal audit and supplier audit plans, CAPA closure, 8D customer complaints, deviation management, and change control.
• Review corrective actions for non-conformities and follow up to ensure timely closure.
• Coordinate and manage audits and inspections by Notified Bodies, Malaysia Medical Device Authority (MDA), and second-party audits by customers from Europe and the United States.

Pay: RM6,500.00 - RM7,800.00 per month

Benefits:

• Additional leave
• Free parking
• Opportunities for promotion
• Professional development

Work Location: In person