Sr Quality Engineer - Plant

Primary Function/Primary Goals/Objectives: Provide Quality Assurance design review support to plant projects initiated by R.C.E. or other means Assure that the plant validation program is executed consistently with the Abbott Nutrition Validation Policies Coordinate the introduction to the plant of new products, processes and packages Develop Master Work Orders, plant procedures, validation Change Requests (CR), Commissioning, Protocols and Deviations as necessary in support of plant projects, new processes and new packages Perform Plant Quality Assurance functions required by the Instrument Calibration Policy Perform process capability studies on process equipment Analyze Quality Records (QRs) and customer complaint trends and recommend changes as necessary.  Assure that changes to plant utilities avoid backflow or other potential adulteration of product Implement productivity improvement projects, analyze plant quality costs and material variances relevant to Quality Assurance Implement SPC process and procedures throughout plant Perform GMP, IFA, water, backflow, hazard analysis and other quality and compliance audits Perform training regarding new technologies, policies and procedures Major Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system Review RCE's to assure adequate funding to address GMP and potential product hazards and to contribute to the development of appropriate process designs and validation protocols Assist in execution of validation protocols Support initial start-up production after engineering changes and/or after producing new products Perform product assurance reviews and identify key quality issues and assure their resolution; assure new installations comply with Abbott Nutrition standards and GMP Provide Quality Assurance input to the change control program and incorporate Division Quality Assurance standards into working manufacturing procedures Assist in problem identification and resolution on all Quality Assurance projects Audit calibration program compliance, investigate Cal-alerts and review and approve changes on new instrument sheets or Cal-deviation requests Conduct process capability studies for process equipment Assure that quality cost information is utilized Support productivity improvement projects Education: Bachelor's Degree in technical area, Engineering or Food Sciencepreferred.  Master's Degree preferred but not required. Background: Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals B. S. Degree plus seven years of relevant experience in Quality Assurance, Manufacturing or Engineering experience, and demonstrate competencies in process validation M.S. Degree plus five years of relevant experience in Quality Assurance, Manufacturing or Engineering The A.S.Q. Certified Quality Engineering Certificate may substitute for part of the experience requirement Accountability/Scope/Budget: Proper execution of this function will help assure that Division projects meet scheduled start-up dates on-time and with a minimum of redesign Quality Assurance involvement in project timing can directly impact profitability by promoting processes that reduce or eliminate scrap, and that operate more efficiently thereby promoting GMP Quality Engineers are involved in all levels of projects by dollar value from simple maintenance work orders to multi-million dollar installations Incumbent possesses the abilities to work with an experienced Senior Project Leader, Quality Engineer or Manager in identifying quality issues and approaches to their resolution This position requires moderate supervision 30903722
Salary Range: NA
Minimum Qualification
8 - 10 years

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