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Quality Assurance Engineer - Medical Devices jobs in United States
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Gandiv Insights LLC · 3 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

Quality AssuranceFDA regulationsISO 13485Bachelor’s degreeLife Sciences knowledgeCross-functional collaboration

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

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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 Stage
Company data provided by crunchbase