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Quality Engineer - Med Device

Company: Michael Page
Location: Durham
Posted on: January 15, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryLead product and process improvements by collecting, compiling, reporting and analyzing data. Drive continuous improvement projects relating to both engineering and product development activities..Client DetailsConfidential manufacturing company - medical device and pharmaDescription* Plan, coordinate and own quality subsystems such as design control, risk management, design verification, design validation, process validation, etc.* Perform design review inspections, design control reviews, and other quality and regulatory associated activities, working closely with an engineering team of various disciplines and technical aptitudes* Documentation, technical writing and reporting of quality engineering functions for FDA forms, submissions, approvals and trackingProfile* Minimum 5 years of quality or regulatory compliance experience in the medical device and/or pharmaceutical industries (other regulated industries may be considered).* Or equivalent combination of education and experience.* Previous use of Reliance electronic quality management system or equivalent.* Quality System Auditor / Lead Auditor certification desired.Job OfferSalary, 401k match, Vacation, PTO, health insurance, and benefitsJob Requirements:Plan, coordinate and own quality subsystems such as design control, risk management, design verification, design validation, process validation, etc. Perform design review inspections, design control reviews, and other quality and regulatory associated activities, working closely with an engineering team of various disciplines and technical aptitudes Documentation, technical writing and reporting of quality engineering functions for FDA forms, submissions, approvals and trackingSDL2017

Keywords: Michael Page, Durham , Quality Engineer - Med Device, Other , Durham, North Carolina

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