Job Title:
Instrument Quality Supervisor / Manager
Wages:
Face to face
Location of work:
Luohu District, Shenzhen City, Guangdong Province - -
Department:
Social Recruitment
Number of people to be recruited:
1
Nature of work:
Full-time
Age limitation for work:
3-5 years
Educational background:
Bachelor degree or above
Age:
Gender:
No limit
Time of issue:
Description of position:
Job requirements:
1. Bachelor degree, major in electronics, machinery, biomedical engineering and other related majors;
2. At least 3 years of medical device quality management experience, IVD medical product quality working experience;
3. Familiar with 13485, medical regulations, CE, FDA and other relevant policies and regulations, with internal auditor certificate;
4. Have the professional skills to guide or supervise all departments of the enterprise to implement the medical device quality system and the ability to solve practical problems;
5. Honest, rigorous, strong logical ability, serious and responsible, proactive.
Job responsibilities:
1. Be responsible for instrument quality management, ensure that the quality management documents meet the requirements of national standards and regulations, and ensure the effective operation of the process.
2. Establish and improve the quality control of the production process, give review conclusions for systematic or serious quality abnormalities and potential quality problems, timely instruct relevant units to formulate corrective and preventive measures, and confirm their effectiveness and actual implementation.
3. Be responsible for the product inspection of raw materials, purchased parts, outsourced parts, semi-finished products and finished products of the company.
4. Be responsible for the analysis and improvement of customer quality feedback information, ensure that all work is carried out in the way required by the company and customers, and ensure that all customer satisfaction indicators are under control.
5. Be responsible for the management of the company's measuring equipment, formulate the procurement plan, regularly calibrate and maintain the measuring equipment, and implement the annual internal audit and management review as planned.
6. Assist in product registration and cooperate in completing the physical examination of certification and registration at home and abroad;
7. Other work arranged by the leader.