Quality Engineer

Quality Engineer
Newark, DE
12-month contract to start with
 
General Description: 
The QE will be responsible for change projects, technical documents, and software: 
 • 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: spreadsheet and software, medical technology, analytical testing, chemistry, bio/protein chemistry & purification, biology, bio processing, organics, and physical chemistry of solids. 
 • 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, 
 • create project plans, 
 • create various types of documents, 
 • estimate timeline, 
 • use necessary tools and resources to complete the projects per plan. 
 
 Functions and responsibilities include: 
- Learn the Quality Change Process required in the Quality Control and Operations area. 
 - Follow the Quality Change Process to implement various changes categorized by projects. 
 - Plan, author, document, and execute the projects. 
 - Formatting, writing and editing of very complex technical documentation 
 - Develops, recommends and implements technical documentation changes to meet regulatory quality requirements and SAP based manufacturing system needs. 
 - Strong background with documented evidence of having worked in technical writing at the industry level. 
 - Understand the basics of Quality Control, Testing, Chemistry and Biology. 
 - Knowledge of FDA regulated environment. 
 - 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. 
 - Background in production processes relative to chemical and physical chemistry 
 - Familiar with basic laboratory techniques used in medical technology or chemistry lab. 
 - Strong computer skills in the knowledge of Microsoft Word and Excel, and macros. 
 - Strong communication and interpersonal skills. 
 - Must be able to work independently and be able to multi-task and prioritize daily work. 
 - Identifies problems as they occur and takes appropriate steps to solve them. 
 - 
 The incumbent must have hands-on experience in medical technology, validations, position is focused on equipment, test methods and /or process validations, with experience in the various phases of validations: 
 o Protocol initiation 
 o Gaining protocol approval 
 o Support execution 
 o Authoring all documents including the final report. 
 
 Education: 
- 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 or Computer Science background
 
Thanks and Regards,
Imran (EMU) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-402-4704 Fax 510-623-5055 
Imran@apninc.com (Google Hangouts)
linkedin.com/in/imranshikalgar

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