Gandiv Insights LLC · 1 day ago
Product Quality Engineer
Princeton, NJ
Contract
Onsite
Entry, Mid Level
2+ years expGandiv Insights LLC is seeking a Quality Engineer to support complaint investigations, CAPA, and compliance activities in an FDA-regulated pharmaceutical/medical device environment. The role involves leading product complaint investigations and ensuring compliance with various FDA regulations.
Information Technology & Services
Responsibilities
Lead and support product complaint investigations, root cause analysis, and CAPA activities
Ensure compliance with FDA QSR, Design Controls, ISO 13485, EU MDR, ISO 14971, GMP, and GDP
Perform data analysis and trending to identify product risks and failure modes
Assess product and design changes for quality and risk management impact
Collaborate with R&D, Engineering, Operations, and Quality teams
Support FDA and Notified Body audits
Qualification
Required
Bachelor's degree in Engineering
2–5 years of Product/Quality Engineering experience in an FDA-regulated industry
Preferred
Test method validation, DOE, and verification/validation experience
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