QUALITY SPECIALIST ( BATU KAWAN)

PMA Manufacturing Sdn Bhd; George Town; On-site; MYR 56,000 - 78,000; Full time

Job summary

PMA Manufacturing Sdn Bhd in Penang is seeking a Quality Assurance/QC Inspector to inspect incoming materials and finished products, document results, and ensure compliance with ISO9001, ISO13485, MDA, and cGMP. You will identify non-conformances, perform measurements, and supervise quality control on the shop floor.

You will also train operators, maintain traceability, and support quality improvement initiatives, while ensuring proper labeling and sample storage.

Qualifications

• Bachelor’s degree in science, Chemistry, Microbiology, Pharmacy, or related field.
• Certification in quality control is preferred.
• Strong understanding of quality standards, testing and aseptic techniques.
• Ability to work on the shopfloor and handle routine inspections.
• Basic documentation and reporting skills.

Responsibilities

• Inspect incoming materials from suppliers and outgoing products for shipping.
• Document products and materials that fail to meet quality expectations.
• Identify, document, and report non-conformances and quality defects.
• Ensure segregation, labeling, and status identification of materials and products.
• Interpret drawings and specifications to understand acceptance criteria.
• Conduct product inspections such as dimension measurements and functionality tests.
• Record all device, production and performance outcomes during inspections.
• Maintain sample storage and traceability.
• Monitor compliance with ISO9001, ISO13485, MDA, cGMP, SOPs, and quality procedures on the shopfloor.
• Perform line and area clearance and hygiene inspections.
• Train production team on quality control concerns as needed.
• Supervise production quality control throughout the process.
• Perform visual inspection for damage, contamination, or debris.
• Operate multiple inspection equipment used for products.
• Provide feedback to QA/QC teams on recurring issues and improvements.
• Follow quality standards, safety, compliance and company policies.

Skills

Attention to detail

MS Office

Communication skills

Quality standards knowledge

GMP knowledge

Documentation skills

Shopfloor inspections

Education

Bachelor's degree in science, Chemistry, Microbiology, Pharmacy, or related field

Certification in quality control is preferred

Tools

MS Office

Job description

Inspects, monitors and documents the incoming and outgoing PMA products/materials/processes against established specifications and quality standards. Conducts tests, performs measurements, take samples and over sees production processes as per established acceptance criteria.

Specific Duties

1. Perform quality inspection on all incoming materials from supplier/vendor and outgoing products for shipping.
2. Inspect all product for Good/Rejects and document all products & materials that fails to meet the quality expectations.
3. Identify, document, and report non-conformances and quality defects
4. Ensure segregation, labelling, and status identification of materials and products
5. Able to comprehend drawings and specifications related to incoming and outgoing product & materials to understand the requirements of acceptance criteria.
6. Perform product inspections such as dimension measurement, functionality test of the final product as per acceptance criteria.
7. Document all the device, production and performance records with each outcome during inspection with on time completion.
8. Ensure sample storage, labelling, and traceability
9. Monitor day-to-day compliance with ISO9001, ISO13485, MDA, cGMP, SOPs, and quality procedures on the shopfloor
10. Perform line clearance, area clearance, and hygiene inspections
11. Train production team on the quality control concerns whenever necessary.
12. Quality personnel to supervise the production process throughout production.
13. Perform visual inspection to check material/product/packaging are free from any type of damage, contamination, dirt or debris.
14. Able to handle multiple equipment used for quality inspection on the product.
15. Have basic knowledge about Quality Management System (QMS), Good Manufacturing Practises (GMP), Good Documentation Practices (GDP) and Cleanroom Environment condition and controls.
16. Able to train operators based on established work instructions and procedures on processes.
17. Responsible for following quality standards, safety, compliance, and company policies/practices.
18. Participate in quality improvement initiatives
19. Provide feedback to QA/QC teams on recurring issues and improvement opportunities
20. Perform other tasks, projects or duties as assigned by management whenever deemed necessary.

Qualifications

1. Bachelor’s degree in science, Chemistry, Microbiology, Pharmacy, or related field, Certification in quality control is preferred.
2. A minimum of 2 years’ experience
3. Working knowledge of MS Office.
4. Attention to detail with excellent technical and math skills.
5. Strong understanding of quality standards, testing and aseptic techniques.
6. Strong attention to detail and observational skills
7. Good understanding of cGMP and quality procedures
8. Ability to work on the shopfloor and handle routine inspections
9. Basic documentation and reporting skills
10. Good communication and coordination skills