Quality Assurance Specialist

Pma Manufacturing Sdn Bhd; George Town; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Quality Assurance Specialist to ensure product compliance with high regulatory standards. The successful candidate will have a strong foundation in microbiological sciences, with experience in quality control and documentation. You will assist in regulatory audits and support continual quality improvement processes within the company.

Qualifications

• 3+ years of experience in quality control/assurance roles.
• Familiarity with ISO 9001, ISO 13485, FDA standards.
• Proficiency in Bahasa Malaysia and English; Mandarin is a plus.

Responsibilities

• Assisting in design and development of new products.
• Supporting Quality department activities for compliance.
• Conducting root cause analysis for quality issues.

Skills

Microbiology

Quality Control

Good Documentation Practices

Communication

Time Management

Education

Bachelor’s in Microbiology/Biotechnology

Tools

MS Office

Job description

1.Contributes significantly to the design and development of new products.

2.Strong foundation in microbiological sciences is a requirement. Proven expertise in microbiology, including theoretical and practical applications.

3.Assist to fulfill the requirements of ISO 9001, ISO 13485, FDA, GMP.

4.Support the Quality department as required in all aspects of quality control, quality assurance and regulatory compliance activities.

5.Stay up-to-date and follow procedures related to the job.

6.Assist with monitoring and maintenance of the applicable procedures and instructions.

7.Control and maintain current version on Device Master Documents on the production floor.

8.Oversee generation and maintenance of Design History Files and ensure compliance to applicable regulations.

9.Participate in risk management meetings and related activities such as verification of risk mitigation implementation in products and processes.

10. Participate in Quality improvement plan for continual improvement in quality system, product and service.

To participate in Quality Audit conducted by internal or external bodies.

To maintain and execute proper documentation including certificates, manuals, SOPs and quality records.

To participate in lab investigation related to rejections and deviations.

To perform root cause analysis and resolve quality related matters.

To participate in review and revision of Standard Operation Procedure, Standard Test Procedure and Qualification Document in Quality Control Laboratories.

To support department KPI and work as a team to achieve overall company quality objective.

Requirements:

1. Experience in design & development and new product development.

2. Bachelor’s in microbiology/ biotechnology or its equivalent field of study.

3. Minimum 3 years of experience in related field.

4. Familiar with EN13727, EN14348, EN13624, EN 14476, EN11737 standards.

5. Experience and knowledge in medical devices is added advantages.

6. Knowledge and experience related to ISO9001,ISO 13485, FDA, MDA, GMP will be an added advantage.

7. Strong knowledge in MS Office, e.g. Excel, PowerPoint, Outlook.

8. Good interpersonal, coordination and communication skills.

9. Systematic, independent and good in time management.

10. Detail-minded, organized, willing to learn.

Able to communicate in English & Bahasa Malaysia. Proficiency in Mandarin would be an added advantage.

Unlock job insights

Salary match Number of applicants Skills match

Your application will include the following questions:

Which of the following statements best describes your right to work in Malaysia? What's your expected monthly basic salary? Which of the following types of qualifications do you have? How many years' experience do you have as a Quality Management Engineer? Have you worked in a role which requires a sound understanding of ISO 9001? How many years of auditing experience do you have? Which of the following Microsoft Office products are you experienced with? How much notice are you required to give your current employer?

To help fast track investigation, please include here any other relevant details that prompted you to report this job ad as fraudulent / misleading / discriminatory.

What can I earn as a Quality Assurance Specialist