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.
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.
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.
• 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.
• 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.