Spec QA
Core
Specializes in specific subsections of the Quality Management System (e.g., Device Master Records, customer complaints, recalls) to build and maintain quality documentation and processes.
Role type
Quality Assurance Specialist
Builds
Quality documentation, processes, and compliance reports
Domain
Medical Devices / Manufacturing
Required skills
Quality Management Systems (QMS), FDA regulations (21 CFR 820), ISO 13485, ERP system analysis, product specifications, manufacturing tolerances, engineering drawings, inspection criteria, testing reports, customer complaint analysis, data analysis, MS Office Suite (Excel)
Preferred skills
None stated
Technologies
ERP systems, MS Office Suite
Responsibilities
Develop and implement processes, reports, and procedures; Collaborate with internal and external groups to solve complex problems and ensure compliance; Facilitate meetings with global business units to manage project requirements; Review documentation for completeness and accuracy; Make recommendations to improve quality standards.
Seniority
Mid-level, individual contributor