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Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process. Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software such as Minitab or JMP.
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The consumers, families, caregivers, school system personnel, DHR workers, and others as appropriate, are directly involved in the consumers treatment and discharge planning. Knowledge of principles of play therapy.
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Experience with State Government, Medicaid, CHIP, and DHR business area or health care industry. Knowledge of IIS Administration Multiple JavaScript Frameworks SoftwareAG webMethods InRules SSRS MS Team Foundation Server.
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This position will assist with the development, implementation, and monitoring of the Quality Management System (QMS) to include the Corrective and Preventive Action (CAPA) System, Design Control, Change Control and Records Control, Document Control, Training Records, Device History Records (DHR) and various other elements within the quality systems as it relates to regulatory compliance and Erbe Quality Systems.
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Develop, review, and approve inspection plans, DHR, and product drawings for new products. Supports QMS activities related to Management Review, audits (internal and external), deviations, CAPA, NCR, supplier management, RGA, and etc.
$120,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Six Sigma Certified preferred Working knowledge of Quality System elements including Design Controls, Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), CAPA. Familiarity with SPC, Experimental Design and Statistical Sampling techniques.
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Accurately assess testing data to ensure product specifications are met and DHR is compiled in a compliant manner, according to current cGMP and site SOP's. Perform immunoassay testing on automated and semi-automated instrument platforms.
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Banquet Lead- Tumble Creek Club | Lowe DHR. Members have exclusive access to a Tom Doak designed golf course, Pro Shop, Greathouse fine dining and activity center, Hill House caf, swim and fitness facility, and Sasse Mt. Outpost glamour campsite.
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Note this position would cover second and third shift quality Inspectors and second shift DHR inspectors. Directs and administers the activities of Quality Engineers, Validation Engineers and dotted Supplier Quality Engineer and associated administrators, and/or Quality Inspectors, and/or Quality Systems associates, as applicable.
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Bachelor’s degree or Equivalent in a Life Science, Engineering, or Physical Science. Supports and promotes the safety and industrial hygiene objectives of the plant. Promotes the use of Process Excellence tools to enhance analytical thinking and problem-solving techniques.
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Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labeling, etc. Working knowledge of Quality Tools (i.e. Quality Planning, Quality Costs and Assessment, Basic Statistics, Advance Statistical Techniques, Technical Writing, Metrology & Calibration, Inspection and Testing, Sampling Principles and AQL, TQM, Lean, Six Sigma, etc.
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Responsible for enforcing all plant policies and driving accountability for individual performance Releases/close out production orders as needed, audits DHR compliance, audits production orders to ensure correct material usage, and ensures that monthly cycle counts are completed for all product teams.
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Operate Production Scanner to digitalize DHR (Device History Record). Associate Degree with a quality emphasis Certified Quality Inspector through ASQ. Interact with Purchasing and Planning to attain RMA number and other communication letters to support the closure of NCs.
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May develop, evaluate, implement and maintain technical quality assurance and control systems and standards pertaining to materials, techniques, or company products including ensuring a thorough connection between design controls deliverables (from design planning, requirements development, risk management, design verification/ validation through design transfer) in the DHF to process validation, production and process controls and content captured in the DHR.
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Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.
$151,000 - $266,400 a yearFull-timeExpandApply NowActive JobUpdated Today
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