Quality Leader

Our Client is recognized within the industry  as the leading global producer of plastic hose system solutions, running up the business with more than 70 years，now operateing from its global HQ in Europe,  where Business management, Operations management, Finance, R&D, and Product management are located, Offering the plastics product into Industrial, Household, and Medical Equipment with the sales offices worldwide.  Now with fast moving business growing-up, they are looking for the post as

Job Post: Quality Leader
Job location: Dongguan city

Description of responsibilities:

1.   Responsible for making the work plan and daily management of the process inspection technicians, ensuring the normal operation of the first inspection, process inspection, and shipment inspection in the daily production process
2. Organize department training, guide, and supervise the work of inspection personnel, ensure that PQC personnel strictly comply with relevant laws and regulations, IS013485, GMP, WI/SOP and other relevant specifications
3. Responsible for rechecking inspectors’ test data and results and requiring inspectors to truthfully record all inspection and test conditions, review inspection records and COA release records.
4. Regularly organize relevant departments to analyze the causes of major defects in the process and customer complaints, confirm the implementation of corrective and preventive measures and follow up the effect verification
5. Participate in the evaluation of the transfer process of design and development, formulate and revise the internal control standards and inspection procedures for semi-finished products and finished products.
6. Participate in engineering change review, validation and approval, and confirmation of change execution.
7. Timely response of defective products in manufacturing process, including containment, stop line, approval of temporary measures, etc.
8. Make statistics, update, summary and analysis of inspection data, find improvement direction and implement improvement, and organize relevant departments to make continuous improvement
9. Customer complaint quick response and lead team do 8D or CAPA
10. Other temporary work assigned by department manager.

Qualification requirements:

1. Bachelor degree or above in injection molding, product quality Engineering,

management engineering, biomedical engineering or related major.

2. Familiar with ISO13485, GMP and internal auditor qualification certificate
3. 5 years or above quality control management experience in medical device

manufacturer, including 3 years QC management experience.

4. Skilled in quality tools, such as quality 7 tools, MSA, FMEA, SPC, CP, 8D, 5WHY,

fish bone diagram, etc., familiar with problem processing process

5. Rigorous, responsible, proactive, strong analytical judgment, good communication skills
6. Language requirements: Good English