Quality Engineer
Core
Execute non-conformance investigations, root cause analysis (RCA), and corrective/preventive actions (CAPA) to ensure product and process quality compliance.
Role type
Quality Engineer (Manufacturing/Compliance)
Builds
Validated products, processes, and computerized systems compliant with GxP standards.
Domain
Medical Device Manufacturing / Quality Assurance
Required skills
Non-conformance investigation, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), Validation and Qualification activities, GxP compliance assessment, Risk assessment, Change Request management, Computerized System validation
Preferred skills
Manufacturing process improvement, Cross-functional collaboration, Historical quality performance analysis
Technologies
Computerized Systems, GxP frameworks
Responsibilities
Conduct quality oversight for operations and computerized systems, Support compliance improvement programs, Collaborate with manufacturing to implement process improvements, Review and approve validation activities for new/existing systems
Seniority
Junior to Mid-level, hands-on IC
