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Principal Design Quality Engineer, Risk Management

Company: Abbott Laboratories
Location: irving
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 107,000 colleagues serve people in more than 160 countries JOB DESCRIPTION:ABOUT ABBOTT DIAGNOSTICS: The 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 Irving, TX, currently has an opportunity for Principal Design Quality Engineer, Risk ManagementWHAT YOU'LL DOPrimary function is to review and participate in all aspects of product risk characterization, prioritization and management for On-Market and In-Development activity. It is expected to have a firm understanding of risk management best practices & tools comprehending the identification, analysis, mitigation, tracking and controlling of risks as applied to hardware and software product development. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.Responsibilities:Responsible for implementing and maintaining the effectiveness of the quality system.Risk Management - Understands and applies basic Risk Management principles.Maintains the risk management process including Risk Identification, Risk Analysis, Risk Mitigation, Risk Monitoring and Risk ReductionCoordinates across functional teams in the development & execution of design risk analyses for Design Plans, Design Reviews, Design Change Requests and d/p/u FMEAsPerforms risk assessments for Defect Tracking Support, Technical Review Boards & CAPAsParticipates on the Risk Management Team and establishes system risk documentation including the Risk Management Plan, Risk Management Report, Post Market Risk Evaluation, Fault Tree Analysis, etc.Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.Quality Engineering - Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.Accountability/Scope: Ability to work in a dynamic & fast paced environment. Ability to work on numerous projects in parallel. Must be a strong communicator with peers, team members, and management. Anticipates the impact and risk of decisions and actions at both the project and organizational level. Comprehends the implications & consequences of how proposed changes and project demands will affect both internal & external customers.EDUCATION AND EXPERIENCE YOU'LL BRINGRequiredB.S. in Systems Engineering; Biomedical Engineering; Life Science or closely related discipline is required or relevant combination of education & experience. MS is preferred. 8+ years experience covering the entire design control/risk management process in a team-oriented environment.PreferredPrefer tool experience with Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS. Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.Project experience in hardware and software risk practices, methodologies and techniques, particularly associated with medical devices is a plus.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: Follow 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 , on Facebook at /Abbott and on Twitter @AbbottNews and @AbbottGlobal.JOB FAMILY:Operations Quality DIVISION:ADD Diagnostics LOCATION:United States > Irving : LC-02 ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:No MEDICAL SURVEILLANCE:No 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: EEO is the Law link - Espanol:

Keywords: Abbott Laboratories, Irving , Principal Design Quality Engineer, Risk Management, Other , irving, Texas

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