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Project Quality Engineer - Cincinnati, United States - Guerbet
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.
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.
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.
YOUR ROLE
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.
Carry out other duties, special assignments and projects as assigned by the Site Quality Manager.
YOUR BACKGROUND
Bachelor's degree in a scientific or engineering discipline, or equivalent combination of education, training, and experience. MBA or master's degree in a STEM field preferred.
Minimum of four (4) years of experience in quality systems for Medical Device manufacturing and/or design.
Minimum of two (2) years of experience in Project Management and New Product Introduction.
Experienced in the creation and implementation of SOPs and Work Instructions.
Knowledgeable of standards and regulations applicable to medical devices: FDA 21CFR820 & ISO 13485: 2016, MDSAP, & EU Medical Device Regulation (MDR).
Project Management Professional (PMP) certification preferred.
Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio) and Minitab.