Gandiv Insights LLC · 21 hours ago
Quality Engineer
United States
Full-time
Remote
Mid, Senior Level
4+ years expGandiv Insights LLC is seeking a Quality Engineer to support medical device manufacturing and product lifecycle quality activities. This role ensures compliance with FDA, ISO 13485, and QMS requirements while supporting nonconformance investigations, CAPAs, validations, and continuous improvement initiatives.
Information Technology & Services
Responsibilities
Support manufacturing floor quality activities and daily issue resolution
Review and disposition nonconforming material and lead failure investigations
Develop and maintain work instructions, control plans, and inspection methods
Support CAPA investigations, root cause analysis, and effectiveness checks
Collaborate with R&D, Manufacturing, RA/QA, and Supply Chain teams on quality issues
Support process validation (IQ/OQ/PQ) and equipment qualification documentation
Maintain risk management files (ISO 14971) and support updates (DFMEA/PFMEA)
Participate in internal audits, supplier audits, and support regulatory inspections
Review device history records (DHRs), incoming inspection data, and trend metrics
Drive continuous improvement using Lean / Six Sigma methodologies
Qualification
Required
Bachelor's degree in Engineering, Quality, Biomedical, Mechanical, or related field
4–7 years of Quality Engineering experience in medical devices
Solid knowledge of ISO 13485, FDA 21 CFR 820, and GMP
Experience with CAPA, NC, root cause analysis, validation, and documentation
Strong cross-functional communication and problem-solving skills
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.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase