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Main tasks:
1) According to customer standards and the requirements of the company's quality management system process planning, through comprehensive quality management work, meet customer and applicable regulatory requirements, and improve product quality competitiveness;
2) According to the instructions of the management representative, responsible for organizing the establishment, implementation, supervision, inspection, and improvement of the company's system.
Job responsibilities:
1) Responsible for establishing, implementing, and maintaining the processes required for the quality management system in accordance with the planned requirements, and documenting the quality system processes;
2) Responsible for collecting, reviewing, and supervising the implementation of external documents required by relevant laws, regulations/standards, and stakeholders. When appropriate, propose application conversion requirements
3) Responsible for organizing internal audits and assisting management representatives in conducting management reviews to ensure smooth progress and completion of annual reports
4) Cooperate with the management representative to create and maintain certificates, coordinate with the deployment of second and third party audits, and arrange reception work
5) Responsible for supervising, inspecting, guiding, and improving the operation of various departmental systems in the company, ensuring the effectiveness of the quality management system, and reporting the operation status to the management representative.
6) Develop a business management objective system for this department (including main responsibility objectives), plan measures to achieve the objectives, including measures to address risks and opportunities, to ensure that the department achieves expected results
7) Lead the work of the Quality Assurance Department, responsible for the implementation of departmental responsibilities, achievement of responsibility goals, team building, operation of the quality assurance system, and safety work
8) Responsible for establishing and maintaining quality control modes, including activities related to incoming materials, processes, final inspections, and micro inspections
9) Responsible for monitoring product quality, collecting and outputting quality information; Ensure that system activities are under control
10) Responsible for controlling the quality cost of our department. Hosting quality improvement activities and promoting continuous improvement of product quality
11) Responsible for supervising and inspecting the implementation of quality standards and related specifications during the product implementation process.
12) Responsible for controlling non-conforming products and organizing the review of non-conforming products;
13) Responsible for implementing corrective and preventive measures, supervising the implementation and results of corrective measures
14) Responsible for investigating and responding to feedback and customer complaints
15) Responsible for product traceability management. When traceability is required, organize various departments of the company to trace raw materials, process products, and finished products, and evaluate the traceability results.
16) Responsible for writing monthly quality reports, tracking the implementation of quality meeting resolutions and quality improvement work
17) Responsible for the daily work of the quality department, personnel work arrangement, and ensuring timely completion of work.
18) Responsible for organizing internal training and sharing within the department
19) Assist the management representative in organizing the construction of the internal auditor team
20) Organize the promotion work related to the ISO 13485 management system.
21) The right to propose development plans for the company's quality management system
22) Has the right to veto and exercise the quality judgment of raw materials, packaging materials, semi-finished products, and finished products
23) Manage the daily work of the department
24) The right to receive office supplies and review the purchase of equipment by the department
Job requirements:
1) Bachelor's degree
2) Science and engineering majors are preferred
3) Priority given to those who have worked in quality management in the industry for more than 3 years.
4) Familiar with the establishment, maintenance, and implementation of EN ISO13485 and 21CFR 820 quality management systems
5) Understand the laws and regulations related to product quality in the European Union and the United States
6) Master customer requirements, production control standards, and judgment standards for various defects and defective products
7) Priority will be given to those with quality management experience in disposable sanitary products, fast-moving consumer goods, or related industries
8) Familiar with microbiology and physicochemical laboratory management standards
9) Familiar with the structure, manufacturing process, and process of the product
10) Proficient in using quality control tools such as SPC, MSA, FMEA, etc., possessing basic knowledge of mathematical statistics
11) Be able to accurately determine the conformity of products according to their production control standards and acceptance standards
12) Strong abilities in comprehensive analysis and problem-solving, communication and coordination, and execution
13) Strong sense of responsibility and teamwork spirit, able to withstand certain work pressure
14) Able to communicate in Chinese and possess certain reading and writing abilities
Jayfen Health specialized in producing medical consumables and personal hygiene products.
Jayfen Health Mainly produce medical underpads, surgical OR turnover kits, incontinence pads,
sanitary pads and adult diapers, 90% of products are exported to US, Europe and Australia and the products are widely applied in hospitals, clinics, laboratories and also sold in super markets.
