Gandiv Insights LLC · 19 hours ago
Quality Engineer – Medical Devices
Irvine, CA
Contract
Onsite
Mid Level
3+ years expGandiv Insights LLC is seeking a Quality Engineer to support quality assurance activities within a regulated medical device manufacturing environment. The role focuses on maintaining compliance with FDA and ISO requirements while supporting product quality, process improvements, and risk management initiatives.
Information Technology & Services
Responsibilities
Support Quality Management System (QMS) activities in compliance with FDA 21 CFR Part 820 and ISO 13485
Perform risk management activities including FMEA and risk assessments
Support CAPA investigations, root cause analysis, and corrective actions
Review and approve quality documentation such as SOPs, protocols, and reports
Support internal and external audits, including FDA and notified body inspections
Collaborate cross-functionally with Manufacturing, R&D, and Regulatory teams
Qualification
Required
Bachelor's degree in Engineering or related field
3+ years of Quality Engineering experience in medical devices
Strong knowledge of GMP, QMS, CAPA, and risk management
Experience with audits and regulatory inspections
Excellent documentation and communication 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