景宏医疗
GRAND FUTURE
Grand Future Medical Producte Co., Ltd.
Recruitment post
Administrator Representative / Quality Department Manager
Job Description:
1. Organize the establishment and implementation of a quality management system suitable for the medical devices produced, and maintain its scientific, reasonable, and effective operation, reporting the operation status and improvement needs of the quality management system to the enterprise leader;
2. Implement relevant laws, regulations, systems, and standards related to medical devices.
3. Develop and organize the implementation of the audit plan for the enterprise quality management system, assist the enterprise leader in organizing management reviews as planned, prepare audit reports, and report the review results to the enterprise management.
4. Organize internal quality management training for medical devices in the enterprise, improve employees' quality management capabilities, and strengthen the enterprise's awareness of integrity and compliance with the law;
5. During the supervision and inspection by various levels of drug supervision and management departments at the production enterprise, maintain communication with the inspection team, provide relevant information and materials, cooperate with the inspection work, and organize relevant departments of the enterprise to rectify issues found during the inspection in a timely manner according to requirements;
6. Formulate the company's quality objectives and their implementation, organize, promote, and implement quality policies and objectives, and supervise and assess the completion of quality objectives by various departments;
7. Responsible for the certification of the company's quality management system, formulate plans and preside over the assessment of the quality system.
Job Requirements:
1. College degree or above, major in medical, pharmaceutical, and analytical science and engineering, with more than 5 years of relevant work experience in medical device and consumable enterprises with more than 150 employees, experience in the operation of medical device quality management systems or production and technical management, familiar with relevant medical device products, production, and quality management;
2. Master the IS013485 system and the "Quality Management Standards for Medical Device Production" and other relevant laws, regulations, rules, and standards related to medical devices, and have ISO13485 internal auditor qualifications;
3. Familiar with the quality management work of medical device production, possess the professional skills to guide or supervise various departments of the enterprise to implement the "Quality Management Standards for Medical Device Production" as required, and have experience in receiving inspections from regulatory departments;
4. Possess good organizational and analytical problem-solving abilities, team collaboration spirit, and work responsibility.
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Job Description: 1. Develop sales business for medical products and follow up with customers; 2. Monitor order production status and coordinate business operations; 3. Maintain communication with customers and respond quickly to their inquiries and demands; 4. Complete the compilation and statistical work of various sales reports; 5. Other tasks assigned by superiors. Job Requirements: 1. Education Level: Relevant majors such as International Trade, Finance, Marketing, Medicine, etc., with a college degree or above. 2. Knowledge: Familiarity with relevant business workflow knowledge. 3. Physically healthy and able to adapt to occasional overtime. 4. Work Experience: More than one year of experience as a sales assistant. 5. Others: 1) Proficient in using office software; 2) Innovative ability, good team spirit, and strong communication skills; 3) Good appearance and temperament, cheerful personality, proactive work attitude, patience, attention to detail, and strong sense of responsibility.
Job Description: 1. Responsible for the initiation and control of various internal R&D projects: preparing project development plans, identifying and controlling project risks, product development management, drawing review, project evaluation (DFM), process follow-up, production process, and production approval (PSW); 2. Effectively control the entire process and key stages of project development; 3. Product master BOM (including fixtures, packaging, and drawing collection); 4. 3D product assembly (check assembly gaps and project lists); 5. 2D part drawings (standard assembly tolerances and related requirements); 6. 3D mold design (tolerance reduction principles and mold protection); 7. Product trial assembly testing and required tools and fixtures; 8. Controlled management of the complete product drawing system; 9. Responsible for cross-department communication, effectively controlling customer requirements, and solving quality and management issues encountered during project development; 10. Master the control of the entire project process and coordinate the organization to complete the documentation for each stage of the project; 11. Host project initiation meetings; 12. Complete other tasks assigned by superiors. Job Requirements: 1. College diploma or above, in project management, mechanical, electronic, design, medicine, or related fields; 2. Possess project management skills, familiar with the preparation, process, and acceptance stages of project implementation and their requirements; 3. Proficient in using various office software, with more than 3 years of experience in medical device R&D project management; 4. Strong execution ability, strong sense of responsibility, good communication and teamwork skills; goal-oriented, good at planning and control; 5. PMP certification is preferred; 6. Familiarity with ISO13485 and APQP is preferred.
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Contact Information
Production address: No. 800, Chuangye Road, Ningbo Southern Binhai New Area, Ninghai County, Ningbo City, Zhejiang Province
Telephone:86-0574-65553888
Email:zhangxufeng@nhgf.cn
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