ELITechGroup - A Bruker Company · 10 hours ago
Quality Assurance Associate
ELITechGroup - A Bruker Company is seeking a Quality Assurance Associate to assist in the development and coordination of quality programs supporting various phases of operations. The role involves preparing quality plans, conducting audits, and analyzing quality processes to ensure compliance with established standards.
BiotechnologyHealth CareInformation TechnologyLogisticsManufacturingMedical
Responsibilities
Prepares quality plans, procedures and instructions in accordance with QA policies and requirements. Prepares appropriate documentation for quality control points throughout the manufacturing/assembly processes
Reviews manufacturing and assembly planning for appropriate sequenced quality requirements. Prepares appropriate quality control points throughout the manufacturing/assembly processes
Performs investigative research with discrepant materials and quality processes; compiles information, analyzes issues related to the root causes and initiates corrective action. Monitors and reports progress on failure analyses, corrective and preventive actions
Compiles, analyzes, and tracks corrective action plans and results of supplier and internal activities for effectiveness, and provides feedback and assistance where necessary
Performs problem analysis as to root cause and probable effective corrective action on complex products using statistical techniques and/or specific data as may be available
Compiles and analyzes relevant data and determines effective internal actions to correct and prevent product discrepancies which affect performance and reliability or otherwise do not meet valid customer expectations
Monitors and assists in the department material review activities to ensure that established quality objectives are being met and that adequate procedures and work instructions are in place and are being followed
Conducts or participates in internal quality audits, process/product improvement projects, product design reviews, supplier evaluation surveys, discrepant material review and disposition activities, failure analysis, and statistical evaluation/process control activities to resolve and prevent quality/reliability concerns
Assists with related special projects, as required
Qualification
Required
Three years quality related experience in manufacturing industry
Practical experience/training in quality planning, Corrective/Preventive action systems, quality auditing, root cause analysis, and problem solving are highly desirable
Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, database manipulation and flow charts
Demonstrates working knowledge of ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations
This position interfaces with all levels of the organization, management and staff, and with customers and suppliers; confidentiality is important to this job position
Company
ELITechGroup - A Bruker Company
ELITechGroup is a global leader in in-vitro diagnostics, serving hospitals and diagnostic laboratories in over 100 countries.
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-27Acquired
2010-01-01Private Equity
Recent News
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2025-09-26
2025-07-08
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