Title: Quality Engineer 2
Location: DE - Newark
Duration: 12 months
Description:
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.
Education:
- 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.