Quality Engineering Supervisor
Core
Develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Role type
Quality Engineering Supervisor
Builds
Quality planning, evaluation, process control, records, and document changes for products and services
Domain
Healthcare manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system regulations (ISO 13485, FDA), document control, internal audits, CAPA system, regulatory and customer audit coordination, cross-functional collaboration
Preferred skills
Experience in internal audits, CAPA system participation, knowledge of ISO 13485 and FDA regulations, document control expertise
Technologies
QMS systems
Responsibilities
Develop and implement quality policies and procedures; manage product and service quality planning and process control; manage direct reports to achieve quality goals; coordinate regulatory, customer, and corporate audits; engage with Operations, Maintenance, and Engineering to achieve site savings goals
Seniority
Mid-level supervisor
