Associate I, Quality Operations
Core
Support product quality compliance, resolve non-conformances, and maintain documentation for medical device manufacturing.
Role type
Associate I, Quality Operations (Entry-level IC)
Builds
Medical device products ensuring global regulatory compliance
Domain
Medical Devices / Quality Operations
Required skills
Quality management practices, non-conformance investigation, CAPA management, root cause analysis, statistical problem-solving, validation protocol administration, data tracking and trending
Preferred skills
Engineering degree (Mechanical, Industrial, Biomedical), medical device or pharmaceutical experience, Minitab proficiency
Technologies
Excel, PowerPoint, Minitab
Responsibilities
Monitor product quality and resolve non-conformances, execute product and equipment validations, ensure product and process controls, investigate non-conformance events and lead CAPA, partner with suppliers on corrective actions, track and trend NC/CAPA data, lead product holds and quarantine, support production floor presence, administer validation protocols
Seniority
Entry-level, hands-on IC