Quality Engineer 1

at VIVA USA Inc. in Newark, Delaware, United States

Job Description

The individual will be responsible for laboratory testing on instruments, troubleshooting and test process changes.
Laboratory Testing will include and not limited to: perform test methods on various chemistry, analytical and diagnostic equipment. Strong knowledge of 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: hard/software relative to LIMS and troubleshooting of laboratory systems.
Process changes will include and not limited to: documentation, work instruction, qualification, validation, failure mode analysis, software and process validations.

Specialist aspects:

The incumbent may 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.

Functions and responsibilities include:

Analytical Testing

Understands Quality Control, Testing, Chemistry and Biology as pertains to the Diagnostics industry.
Completes manufacturing related testing and processes for Diagnostic equipment and analyzers.
Background in production processes relative to chemical and physical chemistry, concentration calculations and statistics.
Leads the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment.

Information Systems

Experience with LIMS and information systems.
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: analytical chemistry, equipment maintenance, LIMS, test methods and /or process validations, medical technology.


Ideal candidate will have a B.S. or equivalent degree with 2-7 year experience in a relevant field with basic Chemistry/Biochemistry or Medical Technologist background.

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Job Posting: 1077577

Posted On: Nov 23, 2022

Updated On: Dec 23, 2022

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