Quality Assurance Manager
Listed on 2026-02-03
-
Quality Assurance - QA/QC
-
Healthcare
Medical Science, Data Scientist
A medical diagnostics organization is seeking a Quality Manager to lead and continuously improve the Quality Management System (QMS) supporting both product development and manufacturing. This role partners cross-functionally with R&D, Manufacturing, Regulatory Affairs, and leadership to ensure compliance, product quality, and patient safety in a fast-paced environment.
Key ResponsibilitiesOwn and maintain the Quality Management System (QMS)
Lead internal and external audits
Analyze quality data and drive CAPA and continuous improvement
Ensure compliance with applicable regulatory and quality standards
Oversee quality events, risk management, and complaint handling
Partner with production to resolve manufacturing quality issues
Manage supplier quality issues and product recalls as needed
Hire, train, and develop quality team members
Bachelor’s degree in a relevant scientific field
5+ years of quality experience in medical devices or diagnostics
2+ years of leadership experience
Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, IVDR, and Health Canada
Experience managing a QMS
Background in molecular diagnostics / PCR preferred
to apply online.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).