Project Quality Engineer
Company: Guerbet
Location: Cincinnati
Posted on: May 2, 2024
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Job 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 YoutubeSUMMARY 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 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:Product design processRisk ManagementDesign verification and
validation strategiesProcess validationComputerized System
Validation (CSV)Supplier selectionUsability 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 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.YOUR BACKGROUNDBachelor's degree in a scientific or
engineering discipline, or equivalent combination of education,
training, and experience. MBA or masters 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.by Jobble
Keywords: Guerbet, Kettering , Project Quality Engineer, Engineering , Cincinnati, Ohio
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