- Monitor and collect China medical device related laws and regulations, implement national and local quality policies, norms and quality standards issued by Guerbet;
- Establish medical device quality files, implement dynamic management, and urge relevant departments and staff to implement relevant laws and regulations on medical device management;
- Take the duty of GSP quality responsible person and head of quality assurance department, shall be responsible for daily medical device quality management (including procurement, storage, maintenance, sales, returns, transportation and other aspects of quality management); Ensure the operation of GSP quality system complies with applicable regulatory standards and HQ's requirements, coordinates and performs internal and external audits as well as supplier audits, including managing CAPA in accordance with applicable global policies;
- Organize the formulation of quality management system documents, guide and supervise the implementation of documents, ensure the effective operation, review and improvement of the quality system, and constantly to improve;
- Organize and perform quality management training, including the training about the relevant requirements and standards of regulations, quality control and system operation, and clarify the requirements of system construction and medical device quality control;
- Manage the quality control function and operation access of the computerized system related to medical device management;
- Review of the qualifications of suppliers, products and buyers, and implement dynamic management to ensure their continued legal and effective;
- Handle unqualified medical devices and supervise the handling process of unqualified medical devices;
- Manage the investigation, handling and reporting of local medical device quality complaints and quality incidents according to the HQ and Chinese regulations. Apply a quality risk management approach to address the company's quality issues and utilize risk management tools to identify and mitigate quality and compliance risks. Organize, implement and record medical device quality safety risk consultation;
- As the recall responsible person, manage the recall;
- Manage the collection and reporting of medical device adverse events, and complete the investigation, evaluation, reporting and archiving of adverse events according to the medical device vigilance agreement and procedures of Guerbet HQ and Chinese regulations;
- Organize verification and calibration of related facilities and equipment;
- Organize the quality assurance capability audit and quality supervision of the entrusted transport carrier; Audit the quality assurance ability and product quality supervision of enterprises specializing in providing medical device transportation and storage services;
- Organize quality management self-inspection and special self-inspection, submit self-inspection report on time;
- Participate in quality, repackaging, distribution and other related projects to meet quality requirements and business needs;
- As the contact person with local regulatory authorities and be responsible for inspection readiness inspections and helping to manage any inspections by local authorities;
- File and maintain quality management related documents and records;
- Other responsibilities that should be carried out by the quality responsible person according to Guerbet HQ and Guerbet China
- Medical device related majors (including medical device, biomedical engineering, mechanical, electronic, medical, biological engineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science, computer, law, management, etc.) associate degree or above or medium-grade professional title
- With a background in medical device quality management and have more than 3 years of relevant work experience.
- Familiar with medical device quality research and quality assurance work and with the ability to make correct judgments and guarantee implementation in quality management work.
- Experience in independently handle medical device quality issues, judge, guide, supervise and arbitrate drug quality and its management.
- Possess communication and coordination skills, problem-solving skills, good teamwork spirit, strong ability to withstand pressure, able to handle daily work independently and adapt to business trips;
- Good written English ability.
- Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
- Are joining a company where we value diversity of talents coming from various horizon.
-
HSBC Shanghai, 中国 Permanent - 全职Risk · Global Risk is a thriving and expert risk management function supporting HSBC globally with all aspects of risk management. The team actively manages a varied and dynamic range of risk types, including security, information security, operational, credit, pension, insuranc ...
-
Marriott Hotels Resorts Shanghai, 中国 全职POSITION SUMMARY · The Project Specialist is responsible for supporting the department operations as part of the organization's administrative team. This position will lead tactical initiatives which support department programs. Success in this position is accomplished through an ...
-
DSV Shanghai, 中国Time Type: · Full TimeGeneral Responsibilities 主要工作职责 · The Product Specialist, Pharma is responsible for quality control, assurance, source matter expert · Detailed Responsibilities 具体工作职责 · Ensure that all work assignments are performed on time. · Takes lead in troubleshooting ...
-
eChinaCareers Shanghai, 中国 全职We are looking for English Game Localization Specialists to join a major mobile gaming company in their Shanghai office. This is a full-time position starting as soon as possible. · Job Description · Assist with game translation and linguistic reviews for your native language, pr ...
-
GroupM Shanghai, 中国Description · Position at GroupM Nexus Overview of job · As the SEM manager, you will be responsible for the day-to-day SEM projects' management for your clients. This includes communication with clients, control budget allocation and media performance, output strategy proposa ...
-
Great China
1周前
LRQA Shanghai, 中国 全职Role Purpose · Advisory service is a recognised, world leading professional assurance services organisation, leveraging on its assurance expertise to manage and reduce risk and contribute to a safer world. We specialise in Customer Training Service and project as well as advisor ...
-
Hannover Re Shanghai, 中国 全职If you want to experience how things are done in our office Hannover Re Shanghai, China, start planning your next career step with us and join our collaborative team on a permanent, full-time basis, commencing at the earliest possible date as a Actuarial Assistant . · Your Tasks ...
-
Hannover Re Shanghai, 中国 全职If you want to experience how things are done in our office Hannover Re Shanghai, China, start planning your next career step with us and join our collaborative team on a permanent, full-time basis, commencing at the earliest possible date as a Actuarial Assistant. · Your TasksCl ...
-
PTC Group Shanghai, 中国Vacancy: SSD Specialist Supplier Development · Location: Shangai, China · Our customer is a global innovation and solutions partner, manufacturing low-emission and alternative fuel energy needs. Its mission is to provide next-generation powertrain solutions as markets around the ...
-
HSBC Shanghai, 中国 Permanent - 全职With a reporting line to Senior Risk & Control Manager as the member of Business Control team, this position, as a specialist individual contributor, will engage with all 3 line of defenses internally and regulator externally and assist Head of Business Control to ensure the cons ...
-
PTC Group Shanghai, 中国Vacancy: SSD Specialist Supplier Development · Location: Shangai, China · Our customer is a global innovation and solutions partner, manufacturing low-emission and alternative fuel energy needs. Its mission is to provide next-generation powertrain solutions as markets around the ...
-
HARMAN International Shang Hai Shi, 中国A Career at HARMAN · As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA. When you add that to the challenges we take on and solve together, you'll disc ...
-
Boeing Shanghai, 中国Job Description · At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment f ...
-
Hannover Re Shanghai, 中国 全职If you want to experience how things are done in our office Hannover Re Shanghai, China, start planning your next career step with us and join our collaborative team on a permanent, full-time basis, commencing at the earliest possible date as a Actuarial Assistant . · Your Tasks ...
-
DELTA-SPORT Shanghai, 中国 Permanent employee, 全职Join the Team · DELTA-SPORT is an owner-managed, medium-sized company with over 30 years of experience in the manufacture of · hardware and a reliable, professional partner to the trade. We are a committed, international team of around 300 specialists and · inspire customers wi ...
-
Hannover Re Shanghai, 中国 全职If you want to experience how things are done in our Hannover Re Shanghai Branch, China, start planning your next career step with us and join our collaborative team on a permanent, full-time basis, commencing at the earliest possible date as an Underwriter . · Your Tasks · Un ...
-
HSBC Shanghai, 中国 Permanent - 全职Digital Business Services (DBS) · HSBC Digital Business Services is a pivotal part of the Group, providing essential operational and technical support to our global businesses and helping improve customer service and efficiency. We combine global expertise and technology to help ...
-
Avient Shanghai, 中国General Summary: · Procurement manager has the responsibilities to manage the procurement activities for all business units and sites in China. This role needs to demonstrate strong leadership (cross-functional, cross-regional, cross-BU communications and influence), lead the te ...
-
GE Aerospace Shanghai, 中国 Paid WorkJob Description Summary · Closely work with headquarter and customer on fight test execution for aircraft NPI projects. Responsible for aircraft flight test execution behalf of engine company and onsite issue finding treatment. Support system integration team operation. · Job Des ...
-
HSBC Shanghai, 中国 Permanent - 全职We are currently seeking an experienced professional to join our team. · In this role, you will: · This role assists with the implementation of the Risk and Control strategy as set out by the Head of Business Control and Strategy or team leader. This role will ensure the consis ...
Quality Assurance Specialist - Shanghai, 中国 - Guerbet
描述
Quality Assurance Specialist
At Guerbet, we build lasting relationships so that to enable people to live better . This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve , Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
Main responsibilities
Job requirements
Reason to join US
Much more than a Competitive salary,
We offer continued personal development. When you join Guerbet, you :
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. or you can also call this number
