Quality Assurance Associate
Core
Maintain and administer the Quality Management System (QMS) for a regulated medical device manufacturer, supporting audits, supplier control, and quality events.
Role type
Quality Assurance Associate
Builds
Quality Management System (QMS) compliance and operational quality processes
Domain
Medical devices / Regulated manufacturing
Deliverable
dashboards & analysis
Required skills
Quality Management System administration, Internal and external auditing, Supplier control, Quality KPI monitoring, Root cause analysis, Process validation support
Preferred skills
eQMS implementation, Continuous improvement methodologies
Responsibilities
Maintain and administer the Quality Management System including core SOPs; Support internal and external auditing; Monitor supplier control and performance; Participate in product and process quality event investigations; Assist in equipment and process validation tasks; Monitor and report on quality KPIs.
Seniority
Mid-level, hands-on IC