QMS Specialist 1
bioMérieuxIllinois, United States
Posted October 20, 2025
52000 - 73000 USD year
Full Time
About the Company
BioFire Diagnostics, now part of bioMérieux, is a leader in molecular diagnostics with over 25 years of experience. They specialize in syndromic infectious disease testing through their FDA-cleared and CE-IVD marked assays for numerous pathogens using the BioFire® FilmArray® System. This system offers fast, comprehensive multiplex PCR testing for viruses, bacteria, parasites, yeast, and antimicrobial resistance genes, making it an essential tool for rapid diagnosis in various clinical settings.
Job Description
The Quality Management Systems Specialist at bioMerieux will ensure product standards are met through batch record review, documentation control, training, and audits. This role requires supporting Quality Events, CAPAs, and metrics. The specialist will also provide input on quality improvements and support Continuous Improvement activities, potentially with Technical Engineering.
Requirements
- Perform Quality review of lot batch records for good documentation requirements and paperwork meets process specifications
- Coordinate Change Request workflows and publish controlled documents within Document Control system, LLDC
- Oversee the learning management system.
- Support activities related to Quality Events and CAPA activities
- Support continuous improvement activities
- Provide input for improvement in the Quality Management System
- Perform all work in compliance with company quality procedures and standards
Benefits
- Medical, dental, and vision plans
- Company-Provided Life and Accidental Death Insurance
- Short and Long-Term Disability Insurance
- Retirement Plan including a generous non-discretionary employer contribution and employer match
- Adoption Assistance
- Wellness Programs
- Employee Assistance Program
- Commuter Benefits
- Various voluntary benefit offerings
- Discount programs
- Parental leaves
