Quality Assurance Specialist (29204)

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 www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

Main responsibilities

• 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

Job requirements

• 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.

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• 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.

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. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717