Quality Specialist
Core
Ensuring compliance with US FDA, international medical device regulations, and ISO 13485 quality system requirements while managing manufacturing quality and the quality management system.
Role type
Quality Specialist (Medical Device Manufacturing)
Builds
Compliance with regulatory standards and internal quality systems for medical devices
Domain
Medical Device Manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Calibration program management, GMP and ISO 13485 experience, Microsoft Office proficiency, documentation control, audit support, nonconformance investigation, cross-functional collaboration
Preferred skills
Medical device industry experience, problem-solving
Technologies
Microsoft Office
Responsibilities
Coordinate and manage calibration programs for inspection and test equipment; maintain calibration databases and ensure equipment is calibrated on schedule; review calibration certificates for accuracy and traceability; investigate and document out-of-tolerance conditions; support internal and external audits by providing records and evidence; assist in maintaining the Quality Management System documentation; create and manage role-based training curricula; provide reports to management on quality activities.
Seniority
Entry-level to Junior (0-2 years experience)
