Quality Specialist

Pma Manufacturing Sdn Bhd; George Town; On-site; MYR 36,000 - 48,000; Full time

Job summary

A manufacturing company in Penang seeks a Quality Control Specialist to oversee inspections of incoming materials and outgoing products. This role involves ensuring compliance with quality standards, documenting non-conformances, and training staff on quality issues. The ideal candidate holds a Bachelor's degree in a relevant field, has at least 2 years of experience, and possesses strong attention to detail and technical skills. This position offers a chance to make a significant impact on product quality and safety.

Qualifications

• Minimum 2 years’ experience in quality control.
• Strong understanding of cGMP and quality procedures.
• Ability to perform routine inspections.

Responsibilities

• Perform quality inspection on all incoming materials and outgoing products.
• Document all products and materials that fail quality expectations.
• Ensure compliance with ISO9001 and quality procedures.

Skills

Attention to detail

Technical skills

Math skills

Quality standards understanding

Communication skills

Education

Bachelor’s degree in science or related field

Certification in quality control

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.

Responsibilities

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. 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. 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. 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. 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.

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