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Quality Engineer

Company: Careerbuilder-US
Location: Memphis
Posted on: January 12, 2021

Job Description:

Quality Engineer - EU MDR Quality Engineer RESPONSIBILITIES INCLUDE:* Assure product design history files meet the regulatory requirements of Medical Device Regulation (MDR 2017.745), internal quality system and other applicable regulations.* Apply knowledge of ISO 14971 Risk Management; IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle; and other applicable standards to sustaining engineering projects.* Serve as primary quality representative on one or more EU MDR project teams Ensure risk management documentation is updated in coordination with activities, and interfacing with project team members including engineering, regulatory, marketing, change management, post market surveillance, and production.* Produce technical reports to support product changes or quality assurance investigations.* Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.* Makes decisions and proposes solutions based on calculated risks identified through data analysis.* Evaluate procedures and processes within the quality system to identify areas for improvement. Recommend solutions to identified problems.* Coordinate activities with Quality Engineering Management and report regularly on the progress of activities.* Participate in meeting departmental goals and objectives; on time project delivery per release project schedule* Travel requirement: Occasional domestic travel may be required less than 10%EDUCATION--REQUIREDBachelor's degree in engineering or equivalent scientific discipline YEARS OF EXPERIENCEPreferred experience includes 4+ years at medical device company serving as a Quality Engineer supporting design control teams with a BS degree. Alternative considerations include 4+ years in Quality Assurance in a GMP environment. 2+ year's experience with a Master's degree.Why Kelly--?As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work-just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined. About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.#KellyGTS

Keywords: Careerbuilder-US, Memphis , Quality Engineer, Other , Memphis, Tennessee

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