Quality Engineer 2

Title: Quality Engineer 2       
Location: DE - Newark
Duration: 12 months
The individual will be responsible for MedTech laboratory testing on instruments, information systems, troubleshooting and test process changes. 
 • Laboratory Testing will include and not limited to: perform test methods on Diagnostic Analyzers of various platforms, understand and follows GLP and GDP as per clinical chemistry practices. 
 • Instrument Systems maintenance and Testing will include and not limited to: Dimension, Dimension Vista, Atellica, Stratus CS, Cobas. Additional familiarity a plus: Advia, Centaur, Immulite. 
 • Instrument information system will include and not limited to: hardware/software relative to LIMS, data communications and troubleshooting of laboratory systems. 
 • Types of changes will include and not limited to: documentation, work instruction, qualification, validation, failure mode analysis, software and process validations. 
 • Work will include: gathering of any necessary information, drafting, editing, coordinating information and needs with various area leads and managers, and implementing complex technical testing or production processes, and change documentations. 
 • The focus of the documentation is in the areas of, and not limited to: testing process and datasheet, spreadsheet and software. 
 • These tests and procedures impact all current diagnostics platforms at the site. The efforts are categorized into projects leading to quality improvements and production systems implementation. 
 Specialist aspects: 
 The incumbent will be involved with multiple projects from a change and troubleshooting project perspective. Tasks will vary and involve: 
 • Understanding the Quality Control processes 
 • learning the change process used at the site, 
 • following these procedures, 
 • Will work with a team on project plans, create or change documents, estimate timeline, and use various tools. 
 Time frame: 
 The position is planned for a 12-month period. Business needs may require additional periods. 
 Functions and responsibilities include: 
 MedTech Analytical Testing 
 • Completes manufacturing related testing and processes for Diagnostic Analyzers. 
 • Leads the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment. 
 • Understands Quality Control, Testing, Chemistry and Biology as pertains to the Diagnostics industry. 
 • Background in production processes relative to chemical and physical chemistry, concentration calculations and statistics. 
 • Familiar with basic laboratory techniques used in medical technology or chemistry lab. 
 Information Systems 
 • Strong background with LIMS and information systems, execution and troubleshooting. 
 • Enters data into internal computer systems and generates documents as required. 
 • Strong computer skills in the knowledge of Microsoft Word and Excel, and macros. 
 Operations Quality Processes 
 • Learn and follow the Quality Change Process required in the Quality Control and Operations area. 
 • Develops, recommends and implements technical documentation changes to meet regulatory quality requirements and SAP based manufacturing system needs. 
 • Knowledge of FDA regulated environment and ISO/IVDD standards. 
 • Familiar with GMP, GLP and GDP processes. 
 • Knowledge or familiarity with SAP production system. 
 • Knowledge of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools. 
 Personal Processes: 
 • Strong communication and interpersonal skills. 
 • Must be able to work independently, on a team and be able to multi-task and prioritize daily work. 
 • Identifies problems as they occur and takes appropriate steps to solve them. 
 • Flexibility to work overtime and/or irregular work hours as needed. 
 • Formatting, writing and editing of very complex technical documentation 
 • Plan, author, document, and execute projects. 
 Desirable experiences: medical technology, equipment maintenance, LIMS, validations, test methods and /or process validations, with experience in the various phases of validations. 
 - Ideal candidate will have a B.S. or equivalent degree with 2-7 year experience in a relevant field with basic Medical Technologist, LIMS or Chemistry/Biochemistry background. 

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