Sr Quality Engineer

Company: Abbott
Location: Santa Rosa
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.Senior Quality EngineerSanta Rosa, CADiagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.Our location in Santa Rosa, CA currently has an opportunity for a Senior Quality Engineer. In this role, you will be responsible for quality engineering activities that address quality system implementation and alignment, product/process change management, CAPA program effectiveness, risk management, and supporting facility and laboratory teams in quality compliance of applicable validations and qualifications. You'll partner with operations for process improvement and continuous improvement initiatives.WHAT YOU'LL DOLeading and/or contributing to quality system alignment, product/service, metrics, and process improvement projects.Act as quality assurance subject matter expert for support of validation and qualification activities that may impact material or laboratory controls, facilitating the application of validation/change controls, risk management, quality planning and implementation of validation or qualification plans.Works closely with facilities, commercial, supply chain, information technology, operations, and sister site SMEs to prevent non-conformities and provide solutions to complex issues.Support multiple projects, balancing priorities and resources to meet project and management expectations.Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.Demonstrates good judgment in selecting methods and techniques for obtaining solutions.Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validationsPerform root cause analysis of quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actionsSupports development and review of validation and qualification plans and test scripts. May support projects in multiple quality systems.Support the QI and CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practicesUnderstands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activitiesCarries out duties in compliance with established business policiesDemonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agenciesPerform other duties and projects as assigned EDUCATION AND EXPERIENCE YOU'LL BRINGRequiredBS/BA degree in the field of science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering or equivalent in related field or equivalent experienceMinimum of 5 years' experience in a quality role within the biotechnology industry with 3-5 years of progressively responsible positionsMinimum of 3 years of CAPA system, non-conformity system and quality system process improvement experience.Minimum of 3 years of hands-on risk management experience in maintaining risk management files such as UMFMEA/DFMEA/PFMEA, plans, reports, etc.Minimum of 3 years of manufacturing/quality engineering experience (design controls/change control, process validation, on-market engineering support and risk management) in a regulated environment.Experience with root cause analysis, failure mode analysis, verification, and validationExperience reviewing and approving process or test method validations, equipment qualifications, validations, etc. is required.PreferredPrevious supervisory experience in a manufacturing QA role in the IVD industry and/or DOA (Drugs of Abuse) industry is highly desirableProcess, QMS or Supplier auditing experience desired.Experience with reagent or ELISA manufacturing, or laboratory testing using LC-MS/MS, GC-MS/MS or other analytical methods desired.Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor, etc. desired.Knowledge of FDA QSRs, ISO 13485:2016, ISO 14971 standards and GMP, GLP and GDP requirements.Knowledge of computers and software programs including Word, Excel, Access, Visio, Minitab/statistical packages, PowerPoint and quality management software (Trackwise, Agile, Master Control, etc.).Statistical tools including basic statistical inference, graphical methods, and regression.Experience with process validations, design verification and design validation studiesAble to work on multiple tasks as a team member and/or ability to operate as an individual contributor.Detail-orientated and available for flexible scheduling.WHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career.We offer:A fast-paced work environment where your safety is our priorityProduction areas that are clean, well-lit, and temperature-controlled 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 a 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 LinkedIn at , on Facebook at and on Twitter @AbbottNews.JobSummaryJob number: 30978978Date posted : 2021-04-06Profession: QualityEmployment type: Full timeSDL2017

Keywords: Abbott, Santa Rosa , Sr Quality Engineer, Other , Santa Rosa, California