Quality Engineer II - Risk Management in Pleasanton, CA
Job title: Quality Engineer II - Risk Management in Pleasanton, CA at Abbott
Company: Abbott
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 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream of.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with a high employer contributionTuition reimbursement, the student debt program, and education benefit - an affordable and convenient path to getting a bachelorâs degree.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbottâs Heart Failure (HF) business, weâre developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.As the Quality Engineer II Risk Management, you will Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Perform risk assessments and evaluations for products that conform to established standards and agency regulations.What Youâll Work OnPerform risk evaluations associated with post market data, give guidance to risk evaluations for product development.Perform Health Hazard EvaluationsWorks cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation.Demonstrates compliance 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, and contractors.Proactive in finding quality improvements related to Risk Management processes.Required QualificationsBachelor's degree in engineering or related fieldMinimum 2 years of related work experiencePreferred QualificationsUnderstanding of complaint management and Health Hazard Assessments for on-market (distributed) productMedical device, regulatory environment or pharmaceutical manufacturingCredentials of a Certified Quality EngineerKnowledge of GMP, ISO, FDA regulations, and quality systems auditingStrong 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 mannerStrong organizational and follow-up skills, as well as attention to detailLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives:Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at , and on Twitter @AbbottNews.The base pay for this position is $79,500.00 â $138,700.00In specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: HF Heart FailureLOCATION: United States
Pleasanton : 6101 Stoneridge DrADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Expected salary: $79500 - 138700 per year
Location: Pleasanton, CA
Job date: Thu, 10 Apr 2025 07:07:38 GMT
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Company: Abbott
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 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream of.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with a high employer contributionTuition reimbursement, the student debt program, and education benefit - an affordable and convenient path to getting a bachelorâs degree.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbottâs Heart Failure (HF) business, weâre developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.As the Quality Engineer II Risk Management, you will Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Perform risk assessments and evaluations for products that conform to established standards and agency regulations.What Youâll Work OnPerform risk evaluations associated with post market data, give guidance to risk evaluations for product development.Perform Health Hazard EvaluationsWorks cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation.Demonstrates compliance 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, and contractors.Proactive in finding quality improvements related to Risk Management processes.Required QualificationsBachelor's degree in engineering or related fieldMinimum 2 years of related work experiencePreferred QualificationsUnderstanding of complaint management and Health Hazard Assessments for on-market (distributed) productMedical device, regulatory environment or pharmaceutical manufacturingCredentials of a Certified Quality EngineerKnowledge of GMP, ISO, FDA regulations, and quality systems auditingStrong 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 mannerStrong organizational and follow-up skills, as well as attention to detailLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives:Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at , and on Twitter @AbbottNews.The base pay for this position is $79,500.00 â $138,700.00In specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: HF Heart FailureLOCATION: United States
Pleasanton : 6101 Stoneridge DrADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Expected salary: $79500 - 138700 per year
Location: Pleasanton, CA
Job date: Thu, 10 Apr 2025 07:07:38 GMT
Apply for the job now!
Apply Now