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Quality Engineer II

Company: Abbott Rapid Diagnostics Informatics, Inc.
Location: charlottesville
Posted on: May 3, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:About AbbottThe key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.Our location in Charlottesville VA currently has an opportunity for a QUALITY ENGINEER II. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.WHAT YOU'LL DOIdentify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirementsLead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirementsAssist in the development and execution of streamlined business systems which effectively identify and resolve quality issuesApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesDesign and conduct experiments for process optimization and/or improvementAppropriately document experiment plans and results, including protocol writing and reportsLead process control and monitoring of CTQ parameters and specificationsLead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)Lead the investigation, resolution and prevention of product and process non-conformancesParticipate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)Lead in the completion and maintenance of risk analysisWork with design engineering in the completion of product verification and validationWork with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activitiesSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.EDUCATION AND EXPERIENCE YOU'LL BRINGRequiredBS/BA degree in an engineering or technical discipline required and up to 5 years of relevant technical experiencePreferredUp to 5 years Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. Advanced computer skills, including statistical/data analysis and report writing skillsPrior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspxFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.JOB FAMILY:Operations Quality DIVISION:ARDx Abbott Rapid Diagnostics LOCATION:United States > Charlottesville : 2000 Holiday Drive ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:Yes, 5 % of the Time MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Keywords: Abbott Rapid Diagnostics Informatics, Inc., Charlottesville , Quality Engineer II, Other , charlottesville, Virginia

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