Quality Assurance Specialist
Core
Ensures products, processes, and documentation meet internal, customer, and regulatory requirements in a regulated manufacturing environment.
Role type
Quality Assurance Specialist (Manufacturing/Regulated)
Builds
Quality records, product release documentation, audit reports, and CAPA plans.
Domain
Manufacturing / Quality Management Systems (ISO 9001, ISO 13485)
Required skills
Root cause analysis, Corrective and Preventive Actions (CAPA), audit execution, risk management, document control, trend analysis, process improvement.
Preferred skills
Medical device/biopharma industry experience, FDA-certified environment experience, electronic QMS platforms.
Technologies
Microsoft Office (Word, Excel, PowerPoint), Electronic Quality Management Systems.
Responsibilities
Review and approve quality/product-release records; investigate quality issues and nonconformances; initiate and support CAPAs; perform internal and supplier audits; analyze quality data to identify trends; support new product development design controls.
Seniority
Mid-Senior level (5+ years experience)
