AddressRequired Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
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
SUMMARY OF POSITION:
This position is responsible for providing Quality oversight of New Product Introduction (NPI), Product Remediation, and Continuous Improvement projects, having major impact on Quality performance and the company’s ability to market products in accordance with US and international regulations.
Responsibilities:
Perform duties as the Quality representative for New Product Introduction (NPI) and/or Product remediation projects.
Ensure compliance of the Design History File (DHF) with applicable procedures, standards, and regulations.
Ensure that projects and new products meet applicable QMS, statutory, and regulatory requirements.
Define and track product and process quality requirements throughout the projects.
Provide support and Quality guidance to the Project team, specifically on topics such as:
Product design process
Risk Management
Design verification and validation strategies
Process validation
Computerized System Validation (CSV)
Supplier selection
Usability Engineering
Design transfer
Process engineering change orders related to projects in collaboration with Regulatory Affairs, Quality, Manufacturing, Procurement, and D&E Partners.
Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
Carry out other duties, special assignments and projects as assigned by the Site Quality Manager.
