Gandiv Insights LLC · 7 hours ago
Quality Assurance Engineer - Medical Devices
Gandiv Insights LLC is seeking a Quality Assurance professional to support quality systems and compliance activities in a regulated medical device environment. The role ensures products and processes meet FDA, ISO, and internal quality standards.
Information Technology & Services
Responsibilities
Support QMS activities in compliance with FDA 21 CFR 820 and ISO 13485
Review and approve quality documents (SOPs, CAPA, deviations, change controls)
Support internal and external audits
Assist with investigations and root cause analysis
Collaborate with cross-functional teams
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
2+ years of QA experience in medical devices
Knowledge of FDA and ISO regulations
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
Funding
Current Stage
Growth StageCompany data provided by crunchbase