Quality Engineer

Quality Engineer
Newark, DE 19702
12 months contract to start with
The QE will be responsible for validations and change projects in the Diagnostics quality control environment:
 • Validations will include and not limited to: software, equipment and test methods.
 • Types of changes will include and not limited to: documentation, work instruction, qualification, failure mode analysis, process and design.
 o 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.
 o The focus of the documentation is in the areas of, and not limited to: validation, spreadsheet and software, medical technology, testing procedure, process and datasheet, chemistry, bio/protein chemistry & purification, biology, bio processing.
 o 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 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:
 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 of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools.
 Personal Processes:
 • Strong communication and interpersonal skills.
 • Must be able to work independently and 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.
 Information Systems
 • Strong computer skills in the knowledge of Microsoft Excel and Word, and macros.
 • Strong understanding of information system validation.
 • Enters data into internal computer systems and generates documents as required.
 • Understands manufacturing related testing and processes for Diagnostic Analyzers.
 • 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.
 Desirable experiences: validation, test methods and /or process with experience in the various phases of validations, testing equipment.
 - Ideal candidate will have a B.S. or equivalent degree with 2-7 year experience in a relevant field with basic Medical Technologist, Chemistry/Biochemistry Engineering background.

Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com 

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