QAQC Manager

Reeracoen Recruitment; Simpang Empat (Semanggol); On-site; MYR 20,000 - 100,000; Full time

Job summary

A prominent recruitment agency is seeking a Quality Assurance Manager to oversee and improve the Quality Management System in the pharmaceutical industry. The ideal candidate will have a Bachelor’s degree and at least 5 years of QA/QC management experience. Responsibilities include managing audits, ensuring compliance with ISO standards, and overseeing documentation and supplier quality. This role offers competitive benefits including allowances and corporate insurance.

Benefits

14 days annual leave

Meal allowance: RM140/month

Phone allowance: RM50/month

Attendance allowance: max RM100

Corporate insurance

Medical benefits: GP, dental & optical

Qualifications

• Minimum 5 years of Quality Assurance and Quality Control management experience in the medical or pharmaceutical industry.
• Strong knowledge of ISO 13485:2016 and U.S. FDA QMSR.
• Effective at managing internal and external audits.

Responsibilities

• Manage and improve the Quality Management System (QMS).
• Plan and execute annual QMS activities and audits.
• Coordinate with certification bodies and internal departments for QMS compliance.

Skills

Quality Assurance Management

ISO 13485:2016 Compliance

Internal and External Audits

Root Cause Analysis

Team Leadership

Education

Bachelor’s degree in Engineering or Science

Job description

Manufacturing (Pharmaceutical/Medical Equipment)

Job Description

Summary

• Manage and continuously improve the Quality Management System (QMS), including policies, objectives, audits, corrective actions, and training activities.
• Plan and execute annual QMS activities such as internal audits, ISO audits, and Management Reviews in collaboration with the QMS team.
• Coordinate with certification bodies, customers, and internal departments to ensure ongoing QMS compliance.
• Handle customer feedback, quality‑related complaints, and reporting.
• Oversee document control and environmental control processes.
• Monitor and drive improvement initiatives for supplier quality.
• Oversee incoming and final product inspections, manage non‑conformances, and ensure compliance with specifications.
• Monitor product yields, conduct root cause analysis (RCA), and implement corrective and preventive actions.
• Manage the QAQC department’s organization, manpower planning, talent development, performance evaluation, and annual budget.
• Perform any other duties as assigned by the supervisor in line with departmental and company objectives.

Qualifications

• Requirement

  • Bachelor’s degree in Engineering, Science, or a related field.

  • Minimum 5 years of Quality Assurance and Quality Control (QA/QC) management experience in the medical or pharmaceutical industry.

  • Knowledge of ISO 13485:2016 and U.S. FDA Quality Management System Regulation (QMSR).

  • Experience in managing internal and external audits.

• English Level
• Other Language

  Malay, English

Benefits

• AL: 14 days annually for the first 2 years
• Meal allowance: RM140/month
• Phone allowance: RM50/month
• Attendance allowance: max RM100
• Regular working hour from 8 am to 5 pm Monday – Friday (option to apply for flexi hour)
• Reimbursement on mileage, toll & business trip
• Free & wide parking area
• Corporate insurance GHS & GPA
• Medical benefits: GP, dental & optical
• Other miscellaneous allowance

Working Hours

8:00 AM ~ 5:00 PM M-F

Holiday

Weekend

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