Quality Technician
Core
Support quality and regulatory work for medical bed devices by ensuring accurate Device History Records (DHR), performing audits, and releasing products for distribution.
Role type
Quality Technician (Medical Devices)
Builds
Medical bed devices
Domain
Healthcare / Medical Devices
Required skills
FDA and ISO standards knowledge, organizational/documentation skills, computer skills, attention to detail, data analysis, audit execution, product release procedures
Preferred skills
2-year technical degree, experience with Document Control Systems
Technologies
Document Control Systems
Responsibilities
Ensure Device History Records (DHR) are properly and accurately completed; Serve as a primary point of contact for rapid and effective corrections of quality issues identified with the Device History Records; Provide training to ensure proper completion and accurate GDP used with the Device History Records; Ensure the NCMR's have been properly documented prior to release of the product for distribution; Release the product for distribution by properly signing the Device History Record; Perform audits to include testing and visual inspection of products; Observes, records, and analyzes data to maintain daily audit reports.
Seniority
Entry-level to Mid-level, hands-on IC