Supervisor, Quality Control
Core
Lead daily quality inspection and testing activities for medical devices in a regulated manufacturing environment, supervising technicians and ensuring compliance with FDA and ISO 13485 standards.
Role type
Quality Control Supervisor (Medical Device Manufacturing)
Builds
Medical device products
Domain
Medical device manufacturing
Required skills
Quality inspection, calibration management, environmental monitoring, nonconformance investigation, inventory reconciliation, FDA/ISO 13485/GMP knowledge, team leadership, cleanroom operations
Preferred skills
Associate or bachelor's degree in scientific/technical field, experience with new-product introduction and process improvements
Technologies
ERP systems
Responsibilities
Lead, train, schedule, and develop Quality Control and Calibration Technicians; Oversee incoming, in-process, and finished-goods inspection and testing; Ensure inspection records and quality documentation are accurate and compliant; Partner with Quality, Operations, and Engineering to investigate and resolve nonconformances; Manage the calibration program and support measurement-system improvements; Monitor environmental monitoring and particle-count activities; Coordinate cycle counts, inventory reconciliation, quality holds, and related ERP transactions; Support new-product introduction, process improvements, yield improvement, and manufacturability initiatives; Provide hands-on inspection support when needed
Seniority
Mid-level Supervisor