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Quality Engineer

Company: Cardinal Health
Location: Augusta
Posted on: December 4, 2019

Job Description:

Quality Engineer This position is primarily responsible for identifying opportunities for continuous improvement, formulating corrective and preventive actions, and working to implement those actions in order to improve quality levels and regulatory compliance. Supervisory responsibilities may entail the supervision of Quality Assurance Technicians. Responsible for assisting QA Manager in designing, building, and managing the facility Quality System to achieve compliance with the following regulations: - ISO 13485, Quality Systems - Medical Devices - Quality Management Systems -Requirements for Regulatory Purposes - FDA 21 CFR Part 820, Quality System Regulation (QSR) - FDA 21 CFR Part 11, Electronic Records; Electronic Signatures - FDA 21 CFR Part 803, Medical Device Reporting - FDA 21 CFR Part 806, Medical Devices; Reports of Corrections and Removals - FDA 21 CFR Part 810, Medical Device Recall Authority - Council Directive 93/42 EEC of June 1993 concerning medical devices (Medical Device Directive), as amended by Directive 2007/47/EC - Canadian Medical Devices Regulations, Health Canada SOR/98-282 (CMDR) - Japan Pharmaceutical Affairs Law (JPAL) - ANVISA - Australian Therapeutic Goods (Medical Devices) Regulation - ISO 14971, Medical devices. Application of risk management to medical devices - ISO 14969, Medical devices Quality management systems Guidance on the application of ISO 13485 Ensures products manufactured or processed in the Augusta facility are safe and effective. Manages non critical projects with input from QA Manager. Expected to be able to manage critical projects with little or no direction from QA Manager. The Focus Factory Quality Engineer is primarily responsible for meeting the summary described in the previous paragraph for the Focus Factory they are assigned to support. Accountabilities - Performing and documenting customer complaint root cause investigations. - Performing and documenting root cause investigations related to raw material, product and component rejections. - Writing protocols and performing validations of new/improved materials and processes. - Generating and maintaining Quality System documentation. - Ensuring FDA/ISO/EN compliance in areas of responsibility. - Presenting quality data to Management. - Supporting Production personnel by resolving process and material related quality problems in support of the various manufacturing departments. - Supporting plant cost reduction and process improvement projects through the use of various Quality tools such as FMEA, process capability, Gage R & R, pareto analysis, Quality Windows etc. - Performing regular internal audits of the Quality System. - Performing Quality Systems audits of suppliers. - Revising documents using the AGILE documentation system. (GCO) - Lead and support change control via the Augusta Change Control System and the AGILE Change Request System (CDP). - Environmental, Health and Safety (EHS) is a major cornerstone of this Companys beliefs. Working safely and protecting the environment are an essential part of an employees job performance and all employees are responsible for adhering to plant EHS policies/procedures, report hazardous conditions or risks follow department EHS rules, PPE requirements, Good Manufacturing Practices (GMPs), ISO 13485 regulations and Good Housekeeping procedures. All employees shall operate in a manner that protects the health and safety of its employees/visitors and operate in a manner that conserves energy, natural resources and protects the environment. In addition, all safety related incidents, no matter how slight, must be reported immediately Qualifications : - Education required: 4-year degree in a Scientific/Engineering discipline. - Experience: Minimum of 2 years in a Quality Assurance environment. - Preferred Skills/Qualifications: Knowledge of Quality System regulations and requirements as stated in the position summary. - Skills/Competencies: Strong computer skills. Good organizational skills. - Other Skills: Strong communication, analytical, and leadership skills. Working Conditions: The work environment is an office setting. Occasionally, and expected of this position, the duties require going on the manufacturing floor. The noise level in the manufacturing environment is relatively loud. Hair nets, beard covers and ear protection required while in manufacturing. Rings and exposed jewelry except for a close fitting watch are to be removed. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Keywords: Cardinal Health, Augusta , Quality Engineer, Engineering , Augusta, Georgia

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