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EU MDR Quality Engineer - Tempe, AZ

Company: stellar consulting
Location: Tempe
Posted on: November 22, 2021

Job Description:

Stellar Consulting Solutions is a boutique business and technology consulting company headquartered in Atlanta, GA. We deliver high quality, agile, and experienced workforce for niche technology projects of any scale. We help forward thinking clients to solve specific problems by understanding their needs and align talent that can move fluidly to match skill supply and demand on a real-time basis. Stellar Consulting has a unique combination of technical and digital skills to recruit, engage, and retain qualified talent. We have a stellar reputation for striving to achieve high ethical standards. Our use of Innovative techniques and industry best practices has made us one of the fastest growing boutique firms delivering to enterprise business. Role: Quality Engineer Location: Tempe, AZ Required Qualifications: Demonstrated knowledge of development, manufacturing and quality system requirements for medical devices or comparably regulated environment is required. Ability to create and execute project plans and lead cross functional teams. Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operating management. Strong ability to analyze and use technical data and resources. Proficient in statistical analysis and related software. Ability to apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Ability to lead creation of risk management files Ability to develop solutions with business impact Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies Ability to make and present risk-based decisions Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Ability to create and provide training Problem solving ability Understanding of regulatory requirements including 21 CFR 210, 211, ICH Guidelines, ISO 13485, ISO 14971 Preferred Qualifications: Quality Engineering Certification (ASQ) or equivalent Education and/or Experience: B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Exposure to Biomedical Engineering or Bioengineering is a plus. Minimum of five years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry Minimum of three years' experience in supervisory capacity Thanks and Regards Vineet Tripathi Recruitment Manager Stellar Consulting Solutions, LLC. Phone: 678-935-7282 E-Mail: LinkedIn: NMSDC Supplier of the Year 2018Job Requirements:EU MDR, CAPA, Validaton

Keywords: stellar consulting, Tempe , EU MDR Quality Engineer - Tempe, AZ, Engineering , Tempe, Arizona

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