Quality Manager

Objective:

The Senior Quality Manager is responsible for establishing and maintaining the quality assurance system by monitoring and advising Senior Management on the performance of the quality management system. This is accomplished by producing data, reporting on performance and measuring against set standards. The Corporate Quality Manger has the authority to stop shipments and is independent of manufacturing operations. The Corporate Quality Manager and their team will champion continuous improvement efforts and defect reduction initiatives to affect progressive enhancements of the Quality Management System (QMS).

Primary Responsibilities:

1. Manages and provides leadership to Quality Control department personnel ensuring QMS functions are being documented and updated.

2. Works independently and with other department managers to develop, Initiate and implement changes and activities to improve performance of processes, metrics and product.

3. Educates and trains QC personnel on the proper techniques and metrics for statistical sampling of raw materials, components and finished goods.

4. Directs the investigation and performs root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.

5. Oversees implementation of corrective actions to ensure compliance and effectiveness.

6. Designs, implements and documents procedures for process control, process improvement, testing and inspection.

7. Establishes and implements metrics (process capability, control charts, measurement quality for monitoring system effectiveness and to assist managers to make sound product quality decisions.

8. Establishes system collection and analysis of data to predict trends that may affect product quality.

9. Analyses customers’ product specifications and incorporates them into in-house product specifications.

10. Monitors vendor performance and establishes criteria and rating system for critical vendors.

11. Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.

12. Oversees calibration and testing programs.

13. Organise, plan, execute participate in organic and external quality audits (ISO 13485 / ISO 9001)

14. To communicate with the notified body in taking the lead role for audits and to close any non-conformances from audits.

15. Interfaces with supplier and customer quality representatives concerning quality problems and implementation of effective corrective actions if necessary.

16. Staying abreast of current regulatory trends and changes.

17. Develops quality assurance plans by conducting risk analyses Medical Product Devices registration (MDA) for New Product Introduced (NPI).

Qualifications:

1. BS degree in microbiology, biotechnology or chemistry.

2. Minimum 8–10 years of successful QA leadership of large, complex, multi team initiatives in a manufacturing environment.

3. 6 years and above of working experience as a Quality manager preferably in a manufacturing environment.

4. Proven leadership abilities, excellent time management skills with an attention to detail.

5. Solid command of the English language in both written and oral form.

6. Working knowledge of QMS, ISO and cGMP- ISO13485, ISO9001 & ISO14097

7. Handle the organization licensing such as MDA, FDA & cGMP

8. Must be a certified internal auditor for ISO 13485 or possess internal auditor ISO 13485

9. Must be ISO 13485 Lead Auditor and preferably ISO 19011.

10. Excellent interpersonal & communication skills with a pleasant demeanor.

Job Type: Full-time

Pay: RM7,500.00 - RM8,000.00 per month

Benefits:

• Additional leave
• Free parking
• Health insurance
• Opportunities for promotion

Schedule:

• Monday to Friday