Guerbet
Project Quality Engineer
Guerbet, Cincinnati, Ohio, United States, 45208
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 for the last 95 years, we continuously innovate. We dedicate 10% of our revenue to Research & Development to improve the diagnosis, prognosis, and quality of life of patients.Achieve ,
Cooperate ,
Care , and
Innovate
are the values that we share and practice daily.Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but it is 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 a major impact on Quality performance and the company's ability to market products in accordance with US and international regulations.YOUR ROLEPerform 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:Design verification and validation strategiesProcess validationComputerized System Validation (CSV)Usability EngineeringDesign transferProcess 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 that 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.YOUR BACKGROUNDBachelor'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).Quality professional certification, such as ASQ CSSGB, CSSBB, CQA, CRE, and/or CQE preferred.Project Management Professional (PMP) certification preferred.Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio) and Minitab.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 the quality of patients' lives all over the world.Are joining a company where we value diversity of talents coming from various horizons.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.
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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 for the last 95 years, we continuously innovate. We dedicate 10% of our revenue to Research & Development to improve the diagnosis, prognosis, and quality of life of patients.Achieve ,
Cooperate ,
Care , and
Innovate
are the values that we share and practice daily.Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but it is 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 a major impact on Quality performance and the company's ability to market products in accordance with US and international regulations.YOUR ROLEPerform 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:Design verification and validation strategiesProcess validationComputerized System Validation (CSV)Usability EngineeringDesign transferProcess 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 that 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.YOUR BACKGROUNDBachelor'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).Quality professional certification, such as ASQ CSSGB, CSSBB, CQA, CRE, and/or CQE preferred.Project Management Professional (PMP) certification preferred.Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio) and Minitab.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 the quality of patients' lives all over the world.Are joining a company where we value diversity of talents coming from various horizons.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.
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